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Saturday, 31 March 2012

Cytra-2 Oral Solution

Dosage Form: oral liquid
Cytra-2 Oral Solution A Sugar-Free Systemic Alkalizer

Cytra-2

Oral Solution

Rx Only

NDC 60258-001-16

DESCRIPTION

Cytra-2 Oral Solution is a stable and pleasant-tasting systemic alkalizer containing sodium citrate and citric acid in a sugar-free base. It is a nonparticulate neutralizing buffer.

CYTRA-2 contains in each teaspoonful (5 mL):

Sodium Citrate Dihydrate......................500 mg

Citric Acid Monohydrate.......................334 mg

Each mL contains 1 mEq Sodium Ion, and is equivalent to 1 mEq Bicarbonate (HC03).

INACTIVE INGREDIENTS:

propylene glycol, sorbitol, polyethylene glycol, sodium benzoate, sodium saccharin, grape flavor, and purified water.

Cytra-2 Oral Solution - Clinical Pharmacology

Sodium citrate is absorbed and metabolized to sodium bicarbonate, thus acting as a systemic alkalizer. The effects are essentially those of chlorides before absorption and those of bicarbonates subsequently. Oxidation is virtually complete so that less than 5% of sodium citrate is excreted in the urine unchanged.

Indications and Usage for Cytra-2 Oral Solution

Cytra-2 Oral Solution is an effective alkalinizing agent. It is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buffering and neutralizing gastric hydrochloric acid quickly and effectively.

Cytra-2 Oral Solution is concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in the recommended dosage. This product is highly palatable, pleasant tasting, and tolerable, even when administered for long periods.

Contraindications

Contraindicated in patients with sodium-restricted diets, with severe renal impairment, or known hypersensitivity to any of the ingredients.

Precautions

Cytra-2 Oral Solution should be used with caution by patients with low urinary output unless under the supervision of a physician. This product should not be administered concurrently with aluminum-based antacids. Patients should be directed to dilute adequately with water and preferably, to take each dose after meals to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary edema, and toxemia of pregnancy. Periodic examinations and determinations of serum electrolytes, particularly serum bicarbonate level, should be carried out in those patients with renal disease in order to avoid these complications.

Adverse Reactions

Cytra-2 Oral Solution is generally well tolerated, without any unpleasant side effects, when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of alkalosis, especially in the presence of hypocalcemia.

Overdosage

Overdosage with sodium salts may cause diarrhea, nausea, and vomiting, hypernoia, and convulsions.

Cytra-2 Oral Solution Dosage and Administration

Cytra-2 Oral Solution should be administered by diluting in water, followed by additional water, if desired. SHAKE WELL BEFORE USING.

For Systemic Alkalization:

Usual Adult Dosage: 2 to 6 teaspoonfuls (10 to 30 mL), diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician.

Usual Pediatric Dose: 1 to 3 teaspoonfuls (5 to 15 mL), diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. For children under two years of age, use is based on consultation with a physician.

As a neutralizing buffer: 3 teaspoonfuls (15 mL), diluted with 15 mL water, taken as a single dose, or as directed by a physician.

How is Cytra-2 Oral Solution Supplied

Cytra-2 Oral Solution is a (colorless, grape flavor) solution and is supplied in the following oral dosage form: NDC 60258-001-16 (16 fl oz bottles).

STORAGE

Keep tightly closed. Store at controlled room temperature, 20°- 25°C (68°- 77°F).

Protect from freezing.

To report a serious adverse event or to obtain product information, contact

800-856-4393.

Manufactured for:

Cypress Pharmaceutical, Inc.

Madison, MS 39110

I351 GSL Rev. 06/11

PRODUCT PACKAGING

The packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 60258-001-16

CYTRA-2

ORAL SOLUTION

(SODIUM CITRATE AND CITRIC

ACID ORAL SOLUTION USP)

500 mg/334 mg per 5 mL

A SUGAR-FREE SYSTEMIC ALKALIZER

EACH TEASPOONFUL (5 mL) CONTAINS:

SODIUM CITRATE DIHYDRATE.......................500 mg

CITRIC ACID MONOHYDRATE.........................334 mg

Each mL contains 1 mEq Sodium Ion, and is equivalent

to 1 mEq Bicarbonate (HC03).

Rx Only

CYPRESS

PHARMACEUTICAL, INC.

16 fl oz (473 mL)

INDICATIONS AND USAGE:

Cytra-2 Oral Solution is a stable systemic alkalizer in a palatable sugar-free base. It is useful in the management of metabolic acidosis especially when the administration of potassium salts is undesirable or contraindicated.

DOSAGE AND ADMINISTRATION: Cytra-2 Oral Solution should be administered by diluting in water, followed by additional water, if desired. SHAKE WELL BEFORE USING.

Usual Adult Dosage: 2 to 6 teaspoonfuls (10 to 30 mL) DILUTED in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician.

Usual Pediatric Dosage: 1 to 3 teaspoonfuls (5 to 15 mL) DILUTED in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. For children under two years of age, use is based on consultation with a physician.

As a Neutralizing Buffer: 3 teaspoonfuls (15 mL) diluted with 15 mL water, take as a single dose, or as directed by a physician.

See attached insert for full prescribing information.

STORAGE: Keep tightly closed. Store at controlled room temperature, 20°- 25°C (68°- 77°F). Protect from excessive heat or freezing.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

To report a serious adverse event or to obtain product information, call 1-800-856-4393.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE

OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Manufactured for: Cypress Pharmaceutical, Inc., Madison MS 39110 L651 Rev. 06/11

CYTRA-2
sodium citrate and citric acid liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	60258-001
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Trisodium Citrate Dihydrate (Sodium Cation)	Trisodium Citrate Dihydrate	500 mg in 5 mL
Citric Acid Monohydrate (Bicarbonate Ion)	Citric Acid Monohydrate	334 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Propylene Glycol
Sorbitol
Polyethylene Glycol
Sodium Benzoate
Saccharin Sodium
Water

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	60258-001-16	473 mL In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2008

Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 08/2011Cypress Pharmaceutical, Inc.

Compare Cytra-2 Oral Solution with other medications

Urinary Alkalinization
Urinary Tract Stones

Thursday, 29 March 2012

Pup Teeth

Generic Name: chamomile, passiflora incarnata top, magnesium phosphate, tribasic calcium phosphate and chamomile granule

Dosage Form: FOR ANIMAL USE ONLY
Pup Teeth

For teething pain relief and stronger teeth

Indications: Homeopathic remedy for common teething and chewing in puppies and kittens.

Dosage: Sprinkle 1 small pinch directly into your pet’s mouth 3-5 times daily as needed.

Caution: Consult your vet if symptoms persist or worsen. Keep this and all medicines from the reach of children.

Ingredients: Each dose contains equal parts of Chamomilla (3X) (HPUS), Passiflora (3X) (HPUS), Mag phos (6C) (HPUS), Calc phos (6C) (HPUS), Chamomilla (30C) (HPUS)

Sucrose (inactive ingredient).

Contains no gluten, artificial flavors, colors or preservatives.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.petalive.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd.

Suite 160

Boca Raton, FL 33487

Phone: 1.877.289.1235

International: + 1.561.999.8857

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

Keep this and all medicines from the reach of children.

Pup Teeth
chamomilla, passiflora, mag phos , calc phos , chamomilla granule

Product Information
Product Type	OTC ANIMAL DRUG	NDC Product Code (Source)	68647-154
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHAMOMILE (CHAMOMILE)	CHAMOMILE	3 [hp_X] in 40 mg
PASSIFLORA INCARNATA TOP (PASSIFLORA INCARNATA TOP)	PASSIFLORA INCARNATA TOP	3 [hp_X] in 40 mg
MAGNESIUM PHOSPHATE (MAGNESIUM CATION)	MAGNESIUM PHOSPHATE	6 [hp_C] in 40 mg
TRIBASIC CALCIUM PHOSPHATE (CALCIUM CATION)	TRIBASIC CALCIUM PHOSPHATE	6 [hp_C] in 40 mg
CHAMOMILE (CHAMOMILE)	CHAMOMILE	30 [hp_C] in 40 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE	20000 mg in 20000 mg

Product Characteristics
Color	white (white sucrose granules)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68647-154-10	20000 mg In 1 BOTTLE, GLASS	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2010

Labeler - Feelgood Health (538418296)

Establishment
Name	Address	ID/FEI	Operations
W. Last		567284153	manufacture

Revised: 09/2010Feelgood Health

Monday, 19 March 2012

Valacyclovir Hydrochloride

Class: Nucleosides and Nucleotides
VA Class: AM800
Chemical Name: 2-[(2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxyl]ethyl ester-l-valine monohydrochloride
Molecular Formula: C₁₃H₂₀N₆O₄•ClH
CAS Number: 124832-27-5
Brands: Valtrex

Introduction

Antiviral; prodrug of acyclovir, a nucleoside.¹

Uses for Valacyclovir Hydrochloride

Genital Herpes

Treatment of initial episodes of genital herpes in immunocompetent¹ ²⁴ ²⁹ ³⁰ or HIV-infected†²⁴ adults and adolescents.

Episodic treatment of recurrent episodes of genital herpes in immunocompetent¹ ²⁴ ²⁹ ³⁰ or HIV-infected†²⁴ adults and adolescents.

Chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent or HIV-infected adults and adolescents.¹ ²⁴ ²⁹ ³⁰ ³³ When used for suppressive therapy in immunocompetent individuals, the risk of heterosexual transmission of genital herpes to susceptible partners is reduced;¹ ³⁵ efficacy for reducing transmission not established in those with multiple partners or in non-heterosexual couples.¹

CDC and others recommend oral acyclovir, oral famciclovir, or oral valacyclovir as drug of choice for treatment of initial episodes of genital herpes and for episodic treatment or chronic suppressive therapy of recurrent genital herpes.²⁴ ²⁹ ³⁰

Herpes Labialis

Treatment of herpes labialis (perioral herpes, cold sores, fever blisters) in adults and adolescents.¹ ³⁴

Safety and efficacy not established in immunocompromised patients.¹

Mucocutaneous Herpes Simplex Virus (HSV) Infections

Treatment of recurrent mucocutaneous HSV infections in HIV-infected adults†.²⁶

Chronic suppressive or maintenance therapy (secondary prophylaxis) against recurrence of HSV infections† in HIV-infected individuals who have frequent or severe recurrences.²⁵ ²⁶

Herpes Zoster

Treatment of acute, localized herpes zoster (shingles, zoster) in adults and adolescents.¹ ⁴ ¹⁰ ¹¹

Treatment of localized dermatomal herpes zoster in HIV-infected adults or adolescents†.³⁸ If cutaneous lesions are extensive or there is clinical evidence of visceral involvement, IV acyclovir should be used for initial treatment.³⁸

Safety and efficacy not established in immunocompromised patients.¹

Safety and efficacy not established for treatment of disseminated herpes zoster.¹

Prevention of Cytomegalovirus (CMV) Disease in Transplant Recipients

Prevention of CMV disease in kidney transplant recipients† at high risk (CMV-seropositive donor).²⁷

Not recommended for prevention of CMV disease in hematopoietic stem cell transplant (HSCT) recipients because the drug is presumed to be less effective than ganciclovir.³¹

Not recommended for primary prevention of CMV disease in HIV-infected individuals because of an unexplained trend toward increased mortality in clinical studies.²⁵ ²⁸

Valacyclovir Hydrochloride Dosage and Administration

Administration

Oral Administration

Administer orally without regard to meals.¹

Patients should maintain adequate hydration during treatment.¹

Dosage

Available as valacyclovir hydrochloride;¹ dosage expressed in terms of valacyclovir.¹

Pediatric Patients

Genital Herpes, Herpes Labialis, Mucocutaneous Herpes Simplex Virus (HSV) Infections, and Herpes Zoster

Oral

Adolescents should receive dosage recommended for adults.²⁴ (See Adults under Dosage and Administration.)

Adults

Genital Herpes

Treatment of First Episodes

Oral

Immunocompetent adults: 1 g twice daily for 7–10 days.¹ ²⁴ ²⁹ ³⁰ CDC suggests duration of treatment may be extended if healing is incomplete after 10 days.²⁴

HIV-infected adults: 1 g twice daily for 7–14 days recommended by CDC and others.³⁸

Initiate therapy within 48 hours of onset of signs and symptoms;¹ efficacy not established if initiated >72 hours after onset of signs or symptoms.¹

Episodic Treatment of Recurrent Episodes

Oral

Immunocompetent adults: 500 mg twice daily for 3 days.¹ ²⁴ ²⁹ ³⁰ Alternatively, CDC recommends 1 g once daily for 5 days†.²⁴

HIV-infected adults: CDC recommends 1 g twice daily for 5–10 days;²⁴ may be continued for 7–14 days.³⁸

Initiate therapy at first sign or symptom of an episode;¹ efficacy not established if initiated >24 hours after onset of signs or symptoms.¹

Suppressive Therapy of Recurrent Episodes

Oral

Immunocompetent adults: 1 g once daily.¹ ²⁴ ³⁰ Alternatively, 500 mg once daily for those with a history of ≤9 recurrences per year.¹ ²⁴ ³⁰

HIV-infected adults: 500 mg twice daily.¹ ²⁴

Manufacturer states safety and efficacy not established beyond a duration of 1 year in immunocompetent or 6 months in HIV-infected individuals.¹

Because frequency of recurrent episodes diminishes over time in many patients, CDC and others recommend suppressive antiviral therapy be discontinued periodically (e.g., once yearly) to assess the need for continued therapy.²⁴ ²⁹ ³⁰

Reduction of Transmission

Oral

500 mg once daily in source partner with a history of ≤9 recurrences per year.¹

Efficacy for reducing transmission not established beyond a duration of 8 months in discordant couples.¹

Herpes Labialis

Oral

Immunocompetent adults: 2 g every 12 hours for 1 day;¹ treatment for cold sores should not exceed 1 day.¹

Initiate treatment at earliest symptom of cold sore (e.g., tingling, itching, burning);¹ efficacy not established if initiated after development of clinical signs of cold sore (e.g., papule, vesicle, ulcer).¹

Mucocutaneous Herpes Simplex Virus (HSV) Infections

Chronic Suppression of Recurrent Episodes

Oral

HIV-infected adults: 500 mg twice daily for chronic suppressive or maintenance therapy (secondary prophylaxis) of HSV infections in those who have frequent or severe recurrences.²⁵

Herpes Zoster

Oral

Immunocompetent adults: 1 g 3 times daily for 7 days.¹

Local dermatomal herpes zoster in HIV-infected adults or adolescents†: 1 g 3 times daily for 7–10 days recommended by CDC and others.³⁸

Initiate therapy at earliest sign or symptom (preferably within 48 hours of rash onset);¹ efficacy not established if initiated >72 hours after rash onset.¹

Special Populations

Hepatic Impairment

Dosage adjustments not recommended for patients with cirrhosis.¹

Renal Impairment

Genital Herpes

Oral

Table 1. Dosage for Treatment of Genital Herpes in Renal Impairment1
Cl_cr (mL/min)	Daily Dosage
First Episodes
≥50	1 g every 12 hours
30–49	1 g every 12 hours
10–29	1 g once every 24 hours
<10	500 mg once every 24 hours
Episodic Treatment of Recurrent Episodes
≥50	500 mg every 12 hours
30–49	500 mg every 12 hours
10–29	500 mg once every 24 hours
<10	500 mg once every 24 hours
Suppressive Therapy of Recurrent Episodes (Immunocompetent with >9 Episodes/Year)
≥50	1 g once every 24 hours
30–49	1 g once every 24 hours
10–29	500 mg once every 24 hours
<10	500 mg once every 24 hours
Suppressive Therapy of Recurrent Episodes (Immunocompetent with <9 Episodes/Year)
≥50	500 mg once every 24 hours
30–49	500 mg once every 24 hours
10–29	500 mg once every 48 hours
<10	500 mg once every 48 hours
Suppressive Therapy of Recurrent Episodes (HIV-infected Individuals)
≥50	500 mg every 12 hours
30–49	500 mg every 12 hours
10–29	500 mg once every 24 hours
<10	500 mg once every 24 hours

Herpes Labialis

Oral

Table 2. Dosage for Treatment of Herpes Labialis in Renal Impairment1
Cl_cr (mL/min)	Daily Dosage
≥50	2 g every 12 hours for 1 day
30–49	1 g every 12 hours for 1 day
10–29	500 mg every 12 hours for 1 day
<10	A single dose of 500 mg

Herpes Zoster

Oral

Table 3. Dosage for Treatment of Herpes Zoster in Renal Impairment1
Cl_cr (mL/min)	Daily Dosage
≥50	1 g every 8 hours
30–49	1 g every 12 hours
10–29	1 g once every 24 hours
<10	500 mg once every 24 hours

Hemodialysis

Usual dose should be administered after hemodialysis.²³

Peritoneal Dialysis

Supplemental doses unnecessary following CAPD or CAVHD.¹

Geriatric Patients

No dosage adjustments except those related to renal impairment.¹ ²³

Cautions for Valacyclovir Hydrochloride

Contraindications

Known hypersensitivity or intolerance to valacyclovir, acyclovir, or any component of the formulation.¹

Warnings/Precautions

Warnings

Hematologic Effects

Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (sometimes fatal) reported in patients with advanced HIV infection and in allogeneic bone marrow or renal transplant recipients receiving high dosages (8 g daily).¹ ²³

General Precautions

Renal Effects

Use of inappropriately high dosage for the level of renal function has resulted in acute renal failure in patients with underlying renal disease.¹

Acyclovir may precipitate in renal tubules if solubility (2.5 mg/mL) is exceeded in intratubular fluid.¹ Maintain adequate hydration.¹

If acute renal failure and anuria occur, hemodialysis recommended until normal renal function returns.¹

CNS Effects

Use of inappropriately high dosage for the level of renal function has resulted in CNS symptoms in patients with underlying renal disease.¹

Genital Herpes

Valacyclovir is not a cure for genital herpes.¹

Avoid sexual contact while lesions and/or symptoms are present due to risk of infecting sexual partners.¹ Infection can be transmitted in the absence of symptoms through asymptomatic viral shedding.¹

Although use for suppressive therapy in immunocompetent individuals with genital herpes decreases the risk for heterosexual transmission, safer sex practices also should be used.¹ Efficacy for reducing transmission not established in individuals with multiple partners or in non-heterosexual couples.¹

Type-specific serologic testing of asymptomatic partners of individuals with genital herpes can determine whether risk for HSV-2 acquisition exists.¹

Valacyclovir has not been shown to reduce transmission of sexually transmitted infections other than HSV-2.¹

Recommended by CDC and others for episodic treatment of genital herpes or chronic suppressive therapy of recurrent episodes in HIV-infected adults and adolescents,¹ ²⁵ ²⁶ but manufacturer says efficacy not established for treatment of genital herpes in HIV-infected individuals and safety and efficacy not established for chronic suppressive therapy in those with advanced HIV disease (CD4⁺ T-cell count <100/mm³).¹

Herpes Labialis

Valacyclovir is not a cure for cold sores.¹

Treatment should not exceed a single day;¹ therapy beyond 1 day does not provide additional clinical benefits.¹

Because of high dosage, use caution when prescribing valacyclovir for treatment of cold sores in geriatric individuals or those with renal impairment.¹ (See Special Populations under Dosage and Administration.)

Safety and efficacy not established for treatment of cold sores in immunocompromised individuals.¹

Herpes Zoster

Safety and efficacy not established for treatment of disseminated herpes zoster or for treatment of herpes zoster in immunocompromised individuals.¹

Specific Populations

Pregnancy

Category B.¹

Lactation

Acyclovir distributed into human milk following oral administration of valacyclovir.¹ Use valacyclovir with caution.¹

Pediatric Use

Safety and efficacy not established in prepubertal children.¹

Geriatric Use

Increased risk of adverse renal or CNS effects.¹ CNS effects reported more frequently in geriatric adults than in younger adults include agitation, hallucinations, confusion, delirium, and encephalopathy.¹

In herpes zoster, longer duration of pain after healing (post-herpetic neuralgia) than in younger adults.¹

Consider age-related decreases in renal function when selecting dosage and adjust dosage if necessary.¹ ²³ (See Renal Impairment under Dosage and Administration.)

Renal Impairment

Decreased clearance; increased risk of adverse renal and CNS effects in patients with underlying renal disease receiving high dosages.¹

Adjust dosage as necessary.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Headache, nausea, vomiting.¹

Interactions for Valacyclovir Hydrochloride

Neither valacyclovir nor acyclovir metabolized by CYP isoenzymes.¹

Specific Drugs

Drug	Interaction	Comments
Antacids (aluminum- or magnesium-containing)	No effect on acyclovir pharmacokinetics¹	Use usual dosages¹
Cimetidine	Potential increased peak plasma concentrations and AUC of acyclovir¹	Not considered clinically important if renal function normal;¹ use usual dosages¹
Digoxin	No effect on pharmacokinetics of acyclovir or digoxin¹	Use usual dosages¹
Probenecid	Potential increased peak plasma concentrations and AUC of acyclovir¹	Not considered clinically important if renal function normal;¹ use usual dosage¹
Thiazide diuretics	No effect on acyclovir pharmacokinetics¹	Use usual dosages¹

Valacyclovir Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Valacyclovir hydrochloride, a prodrug of acyclovir, is rapidly absorbed following oral administration and almost completely converted to acyclovir andl-valine by first-pass intestinal and/or hepatic metabolism.¹ ³⁶

Absolute bioavailability of acyclovir approximately 54% following oral administration of valacyclovir hydrochloride;¹ ³⁶ peak acyclovir plasma concentrations attained within 1.7 hours.³⁶

Food

Administration of valacyclovir with food does not alter acyclovir bioavailability.¹

Distribution

Extent

Although there are no adequate studies using valacyclovir, acyclovir crosses the placenta.¹

Following oral administration of valacyclovir to the mother, acyclovir is distributed into milk.¹

Plasma Protein Binding

13.5–17.9% bound to plasma proteins.¹

Elimination

Metabolism

Valacyclovir hydrochloride rapidly converted to acyclovir and l-valine by first-pass intestinal and/or hepatic metabolism.¹ Acyclovir converted to acyclovir monophosphate, diphosphate, and triphosphate in cells infected with herpesviruses.¹

Neither valacyclovir nor acyclovir metabolized by CYP enzymes.¹

Elimination Route

Valacyclovir principally eliminated as acyclovir;¹ 46 and 47% of an oral dose eliminated in urine and feces, respectively.¹ ³⁶

Half-life

Plasma elimination half-life of acyclovir after oral administration of valacyclovir averages 2.5–3.3 hours.¹ ³⁶

Special Populations

Renal clearance and elimination half-life decreased in patients with renal impairment;¹ half-life averages 14 hours in end-stage renal disease.¹

Pharmacokinetics in geriatric patients vary depending on renal function.¹

Stability

Storage

Oral

Tablets

15–25°C.¹

Actions and SpectrumActions

Valacyclovir is thel-valine ester of acyclovir.¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ Prodrug with no antiviral activity until converted in vivo to acyclovir and subsequently to the active acyclovir triphosphate.¹ ² ⁵ ⁶ ⁷

GI absorption of valacyclovir substantially greater than absorption of oral acyclovir resulting in plasma acyclovir concentrations comparable to those achieved with IV acyclovir.³⁶

Active against Herpesviridae including herpes simplex virus types 1 and 2 (HSV-1 and HSV-2), varicella-zoster virus (VZV), and cytomegalovirus (CMV).¹

Acyclovir highly selective for thymidine kinase encoded by HSV and VZV, which converts acyclovir into acyclovir monophosphate, which is further converted to the diphosphate and then to the active triphosphate via other cellular enzymes.¹ Also exhibits activity against viruses that do not code for this enzyme.¹² ¹³ ¹⁴ ¹⁵ ¹⁶ ¹⁷ ¹⁸ ¹⁹ ²⁰

Inhibits viral DNA replication by competitive inhibition of viral DNA polymerase, incorporation and termination of the growing viral DNA chain, and inactivation of the viral DNA polymerase.¹

Resistant strains of HSV and VZV reported.¹

Advice to Patients

Advise patients that valacyclovir is not a cure for genital herpes or herpes labialis (cold sores).¹

Importance of avoiding sexual contact with uninfected partners while genital herpes lesions and/or symptoms are present since there is a risk of transmission.¹ Genital herpes can be transmitted in the absence of symptoms.¹

Importance of using safer sex practices in conjunction with use of valacyclovir for suppressive therapy of genital herpes.¹

Importance of initiating treatment of genital herpes recurrence as soon as possible following onset of signs and symptoms.¹

For treatment of herpes labialis, importance of initiating treatment immediately following onset of symptoms (tingling, itching, burning) and importance of not using valacyclovir for longer than 1 day.¹

Importance of maintaining adequate hydration during treatment.¹

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

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

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

Preparations

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

Valacyclovir Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	500 mg (of valacyclovir)	Valtrex Caplets (with povidone)	GlaxoSmithKline
		1 g (of valacyclovir)	Valtrex Caplets (with povidone)	GlaxoSmithKline

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Valacyclovir HCl 1GM Tablets (AUROBINDO PHARMA): 30/$315.99 or 90/$899.97

Valacyclovir HCl 500MG Tablets (MYLAN): 30/$185.99 or 90/$525.97

Valtrex 1GM Tablets (GLAXO SMITH KLINE): 30/$365.87 or 90/$1050.46

Valtrex 500MG Tablets (GLAXO SMITH KLINE): 30/$233.81 or 90/$657.9

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 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. GlaxoSmithKline. Valtrex (valacyclovir hydrochloride) caplets prescribing information. Research Triangle Park, NC; 2006 Jul.

2. Jacobson MA, Gallant J, Wang LH et al. Phase I trial of valaciclovir, the l-valyl ester of acyclovir, in patients with advanced human immunodeficiency virus disease. Antimicrob Agents Chemother. 1994; 38:1534-40. [IDIS 332383] [PubMed 7979285]

3. Darby G. Acyclovir—and beyond. J Int Med Res. 1994; 22(Suppl 1):33-42A. [PubMed 8187942]

4. Beutner KR, Friedman DJ, Forszpaniak C et al. Valaciclovir compared with acyclovir for improved therapy for herpes zoster in immunocompetent adults. Antimicrob Agents Chemother. 1995; 39:1546-53. [IDIS 350497] [PubMed 7492102]

5. Gnann JW Jr. New antivirals with activity against varicella-zoster virus. Ann Neurol. 1994; 34(Suppl):S69-72.

6. Easterbrook P, Wood MJ. Successors to acyclovir. J Antimicrob Chemother. 1994; 34:307-11. [IDIS 336425] [PubMed 7829405]

7. Weller S, Blum MR, Doucette M et al. Pharmacokinetics of the acyclovir pro-drug valaciclovir after escalating single- and multiple-dose administration to normal volunteers. Clin Pharmacol Ther. 1993; 54:595-605. [IDIS 324231] [PubMed 8275615]

8. Lampkin TA. Valacyclovir HCl (Valtrex) administration achieves increased acyclovir concentration in multiple populations. Int Pharm Abst. 1994; 31:2291.

9. Shaefer MS. Valacyclovir HCl (Valtrex) provides simplified dosing and increased efficacy in the treatment of herpes virus infections. Int Pharm Abst. 1994; 31:2244-5.

10. The International Valaciclovir Zoster Study Group, Smiley ML. The efficacy and safety of valaciclovir for the treatment of herpes zoster. Proceedings of ICAAC New Orleans 1993. Abstract No. 1203.

11. The International Valaciclovir Zoster Study Group, Smiley ML. Valaciclovir and acyclovir for the treatment of recurrent genital herpes simplex virus infections. Proceedings of ICAAC New Orleans 1993. Abstract No. 1210.

12. Koch-Weser J, Hirsch MS, Swartz MN. Drug therapy: antiviral agents (second of two parts). N Engl J Med. 1980; 302:949-53. [IDIS 113597] [PubMed 6244492]

13. Lerner AM. Acyclovir reaches clinical trial. Ann Intern Med. 1982; 96:370-2. [IDIS 146189] [PubMed 7036819]

14. Weller IV, Carreno V, Fowler MJ et al. Acyclovir inhibits hepatitis B virus replication in man. Lancet. 1982; 1:273. [IDIS 144926] [PubMed 6120286]

15. Colby BM, Furman PA, Shaw JE et al. Phosphorylation of acyclovir [9-(2-hydroxyethoxymethyl)-guanine] in Epstein-Barr virus infected lymphoblastoid cell lines. J Virol. 1981; 38:606-11. [PubMed 6264131]

16. St. Clair MH, Furman PA, Lubbers CM et al. Inhibition of cellular α and virally induced deoxyribonucleic acid polymerases by the triphosphate of acyclovir. Antimicrob Agents Chemother. 1980; 18:741-5. [PubMed 7192534]

17. Tyms AS, Scamans EM, Naim HM. The in vitro activity of acyclovir and related compounds against cytomegalovirus infections. J Antimicrob Chemother. 1981; 8:65-72. [PubMed 6265430]

18. Burns WH, Wingard JR, Bender WJ et al. Thymidine kinase not required for antiviral activity of acyclovir against mouse cytomegalovirus. J Virol. 1981; 30:889-93.

19. McCarthy P (Burroughs Wellcome Co, Research Triangle Park, NC): Personal communication; 1982 Aug.

20. Mar E, Patel PC, Huang E. Effect of 9-(2-hydroxyethoxymethyl) guanine on viral-specific polypeptide synthesis in human cytomegalovirus-infected cell. Am J Med. 1982; 73(Acyclovir symposium):82-5. [IDIS 154027] [PubMed 6285739]

21. Lang DJ, Cheung K. Effectiveness of acycloguanosine and trifluorothymidine as inhibitors of cytomegalovirus infection in vitro. Am J Med. 1982; 73(Acyclovir symposium):49-53. [IDIS 154025] [PubMed 6285732]

22. Pagano JS, Datta AK. Perspectives on interactions of acyclovir with Epstein-Barr and other herpes viruses. Am J Med. 1982; 73(Acyclovir symposium):18-26. [IDIS 156729] [PubMed 6285710]

23. Glaxo Wellcome, Inc, Research Triangle Park, NC: Personal communication.

24. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep. 2006; 55(RR-11):1-95.

25. US Public Health Service (USPHS) and Infectious Diseases Society of America (IDSA) Prevention of Opportunistic Infections Working Group. 2001 USPHS/IDSA guidelines for the prevention of opportunistic infections in persons with human immunodeficiency virus. From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website ().

26. Balfour HH. Antiviral drugs. N Engl J Med. 1999; 340:1255-68. [IDIS 423356] [PubMed 10210711]

27. Lowance D, Neumayer HH, Legendre CM et al. Valacyclovir for the prevention of cytomegalovirus disease after renal transplantation. N Engl J Med. 1999; 340:1462-70. [IDIS 427339] [PubMed 10320384]

28. Feinberg JE, Hurwitz S, Cooper D et al. A randomized, double-blind trial of valaciclovir prophylaxis for cytomegalovirus disease in patients with advanced human immunodeficiency virus infection. J Infect Dis. 1998; 177:48-56. [IDIS 399239] [PubMed 9419169]

29. Anon. Drugs for sexually transmitted infections. Treat Guidel Med Lett. 2004; 2:67-74. [PubMed 15529116]

30. Anon. Drugs for non-HIV viral infections. Treat Guidel Med Lett. 2005; 3:23-32.

31. Centers for Disease Control and Prevention. Guidelines for preventing opportunistic infections among hematopoietic stem cell transplant recipients: recommendations of CDC, the Infectious Disease Society of America, and the American Society of Blood and Marrow Transplantation. MMWR Recomm Rep. 2000; 49(RR-10):1-125.

32. Leone P, Trottier S, Miller JM. Valacyclovir for episodic treatment of genital herpes: a shorter 3-day treatment course compared with 5-day treatment. Clin Infect Dis. 2002; 34:958-62. [IDIS 480416] [PubMed 11880962]

33. DeJesus E, Wald A, Warren T et al. Valacyclovir for suppression of recurrent genital herpes in human immunodeficiency virus-infected subjects. J Infect Dis. 2003; 188:1009-16. [IDIS 516503] [PubMed 14513421]

34. Spruance SL, Jones TM, Blatter MM et al. High-dose, short-duration, early valacyclovir therapy for episodic treatment of cold sores: results of two randomized, placebo-controlled, multicenter studies. Antimicrob Agents Chemother. 2003; 47:1072-80. [IDIS 495732] [PubMed 12604544]

35. Corey L, Wald A, Patel R et al. Once-daily valacyclovir to reduce the risk of transmission of genital herpes. N Engl J Med. 2004; 350:11-20. [IDIS 508984] [PubMed 14702423]

36. Soul-Lawton J, Seaber E, On N et al. Absolute bioavailability and metabolic disposition of valaciclovir, the L-valyl ester of acyclovir, following oral administration to humans. Antimicrob Agents Chemother. 1995; 39:2759-64. [IDIS 358708] [PubMed 8593015]

37. Soul-Lawton J, Seaber E, On N et al. Absolute bioavailability and metabolic disposition of valaciclovir, the L-valyl ester of acyclovir, following oral administration to humans. Antimicrobial Agents and Chemotherapy. 1995; 39:2759-64. [IDIS 358708] [PubMed 8593015]

38. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-15):1-112.

39. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-exposed and infected children: recommendations from CDC, the National Institutes of Health, and the Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53( RR-14):1-92.

More Valacyclovir Hydrochloride resources

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

Valacyclovir Prescribing Information (FDA)

Valacyclovir MedFacts Consumer Leaflet (Wolters Kluwer)

Valtrex Prescribing Information (FDA)

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Cold Sores
Cytomegalovirus Infection
Herpes Simplex, Mucocutaneous/Immunocompetent Host
Herpes Simplex, Mucocutaneous/Immunocompromised Host
Herpes Simplex, Suppression
Herpes Zoster
Multiple Sclerosis
Varicella-Zoster

Friday, 16 March 2012

Havrix

Pronunciation: hep-ah-TY-tiss
Generic Name: Hepatitis A Vaccine
Brand Name: Havrix

Havrix is used for:

Preventing hepatitis A infection.

Havrix is a vaccine. It works by stimulating the body to produce antibodies against hepatitis A infection.

Do NOT use Havrix if:

you are allergic to any ingredient in Havrix, including neomycin

you have had a severe allergic reaction (eg, rash; hives; itching; trouble breathing; tightness of the chest; swelling of the mouth, face, lips, or tongue) to a previous hepatitis A vaccine

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

Before using Havrix:

Some medical conditions may interact with Havrix. 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 are allergic to latex or dry natural rubber

if you have a weakened immune system, fever, infection, or other illness

if you have a bleeding disorder

if you take an anticoagulant (eg, warfarin) or medicine that suppresses your immune system (eg, cyclosporine)

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

Ask your health care provider if Havrix 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 Havrix:

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

Havrix is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Havrix at home, a health care provider will teach you how to use it. Be sure you understand how to use Havrix. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Shake well before each use.

If you miss a dose of Havrix, contact your doctor right away.

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

Important safety information:

It may take at least 2 weeks before Havrix will protect you from hepatitis A. A booster dose is recommended 6 to 12 months later for more complete protection.

Travelers to areas where hepatitis A virus is common should take all necessary precautions to avoid contact with hepatitis A virus (eg, contaminated food and water). Contact the Centers for Disease Control and Prevention for specific travel destination information.

Tell your doctor if you have recently received a vaccine or are scheduled to receive a vaccine.

Havrix should not be used in CHILDREN younger than 12 months old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Havrix while you are pregnant. If you are or will be breast-feeding while you use Havrix, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Havrix:

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:

Headache; loss of appetite; mild fever; nausea; redness, soreness, swelling, or warmth at the injection site; tiredness.

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; unusual hoarseness); numbness or tingling of the arms or legs; seizures; shortness of breath; unusual bruising or bleeding; unusual or severe muscle weakness; yellowing of the eyes or skin.

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: Havrix side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Havrix:

Havrix is usually handled and stored by a health care provider. If you are using Havrix at home, store Havrix as directed by your pharmacist or health care provider. Keep Havrix out of the reach of children and away from pets.

General information:

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

Havrix 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 Havrix. 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 Havrix resources

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

Havrix Prescribing Information (FDA)

Havrix Advanced Consumer (Micromedex) - Includes Dosage Information

Havrix Consumer Overview

Vaqta Prescribing Information (FDA)

Compare Havrix with other medications

Hepatitis A Prophylaxis

Friars' Balsam BP

1. Name Of The Medicinal Product

Benzoin Tincture Compound BP or Friars Balsam BP

2. Qualitative And Quantitative Composition

Storax prepared BP 10.0% w/v

Benzoin sumatra crushed BP 10.0% w/v

3. Pharmaceutical Form

Tincture

4. Clinical Particulars

4.1 Therapeutic Indications

1. As an inhalant for relief of the symptoms of colds.

2. As a mild antiseptic dressing.

4.2 Posology And Method Of Administration

1. Through the mouth and nasal passages.

2. Topical.

1. As an inhalant

Adults, children over 3 months of age and the elderly: Add one 5ml spoonful to a pint of hot, but not boiling water.

The dose may be repeated after 4 hours if required.

The product is suitable for use under this clinical indication by adults, children over 3 months and the elderly.

Not suitable for children under 3 months of age.

2. As an antiseptic

Adults, children and the elderly: Apply undiluted to the affected area twice daily. The product is suitable for use under this clinical indication by adults, children and the elderly.

4.3 Contraindications

Contraindicated in patients with known sensitivity to sumatra benzoin or storax.

4.4 Special Warnings And Precautions For Use

Not suitable for children under 3 months when used as an inhalant.

For external use only.

Keep all medicines away from children.

Caution: Highly flammable. Keep away from a naked flame.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use of this product by the indicated routes is not considered likely to cause any undesirable effects in the above conditions.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

This product is for external use only. Accidental ingestion is likely to cause a severe burning sensation in the mouth and mucous membranes due to the high alcohol content and the bitter taste of the aloes and balsamic acids. Dilution of the product in the mouth will cause the separation of an unpleasant gummy residue. It is considered unlikely that a significant quantity could be swallowed. However the main effects would be those of alcohol intoxication.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Sumatra benzoin has been used as an ingredient in inhalations used in the treatment of catarrh of the upper respiratory tract for many years. It has also been used topically for its antiseptic and protective properties.

Storax has mild antiseptic action.

5.2 Pharmacokinetic Properties

No information available.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Aloes powdered BP, purified water BP, ethanol (96%) BP

6.2 Incompatibilities

None known.

6.3 Shelf Life

25ml: 36 months unopened.

50ml: 36 months unopened.

500ml: 36 months unopened.

2000ml: 36 months unopened.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container


25ml:	glass bottle and plastic cap with liner.
50ml:	glass bottle and plastic cap with liner or white 28mm polypropylene cap with Tamper Evident band and EPE/Saranex liner.
500ml:	glass bottle and plastic cap with liner.
2000ml:	glass bottle and plastic cap with liner.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L.C.M. Ltd.,

Linthwaite Laboratories

Huddersfield

HD7 5QH

England

8. Marketing Authorisation Number(S)

PL 12965/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

11/10/93 19/11/98

10. Date Of Revision Of The Text

March 2005

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable

Monday, 12 March 2012

Efidac 24 Pseudoephedrine

Generic Name: pseudoephedrine (Oral route)

soo-doe-e-FED-rin

Commonly used brand name(s)

In the U.S.

12 Hour Cold Maximum Strength

Biofed

Cenafed

Chlor-Trimeton Nasal Decongestant

Contac 12-Hour

Dimetapp Decongestant

Efidac 24 Pseudoephedrine

ElixSure Congestion Children's

Genaphed

Pediacare Decongestant Infants

Simply Stuffy

Sudafed

Available Dosage Forms:

Capsule, Extended Release

Tablet, Chewable

Tablet, Extended Release

Solution

Syrup

Liquid

Tablet

Capsule

Capsule, Liquid Filled

Suspension

Therapeutic Class: Decongestant

Pharmacologic Class: Alpha-Adrenergic Agonist

Uses For Efidac 24 Pseudoephedrine

Pseudoephedrine is used to relieve nasal or sinus congestion caused by the common cold, sinusitis, and hay fever and other respiratory allergies. It is also used to relieve ear congestion caused by ear inflammation or infection.

Some of these preparations are available only with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Efidac 24 Pseudoephedrine

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

Pseudoephedrine may be more likely to cause side effects in infants, especially newborn and premature infants, than in older children and adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of pseudoephedrine in the elderly with use in other age groups.

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

Clorgyline

Dihydroergotamine

Furazolidone

Iproniazid

Isocarboxazid

Linezolid

Moclobemide

Nialamide

Pargyline

Phenelzine

Procarbazine

Rasagiline

Selegiline

Toloxatone

Tranylcypromine

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.

Guanethidine

Methyldopa

Midodrine

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 pseudoephedrine

This section provides information on the proper use of a number of products that contain pseudoephedrine. It may not be specific to Efidac 24 Pseudoephedrine. Please read with care.

For patients taking pseudoephedrine extended-release capsules:

Swallow the capsule whole. However, if the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

Do not crush or chew before swallowing.

For patients taking pseudoephedrine extended-release tablets:

Swallow the tablet whole.

Do not break, crush, or chew before swallowing.

To help prevent trouble in sleeping, take the last dose of pseudoephedrine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer period of time than recommended on the label (usually 7 days), unless otherwise directed by your doctor. To do so may increase the chance of side effects.

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 nasal or sinus congestion:
- For regular (short-acting) oral dosage form (capsules, oral solution, syrup, or tablets):
  - Adults and children 12 years of age and older—60 milligrams (mg) every four to six hours. Do not take more than 240 mg in twenty-four hours.
  - Children 6 to 12 years of age—30 mg every four to six hours. Do not take more than 120 mg in twenty-four hours.
  - Children 4 to 6 years of age—15 mg every four to six hours. Do not take more than 60 mg in twenty-four hours.
  - Children and infants up to 4 years of age—Use is not recommended .
- For long-acting oral dosage form (extended-release capsules or extended-release tablets):
  - Adults and children 12 years of age and older—120 mg every 12 hours, or 240 mg every 24 hours. Do not take more than 240 mg in 24 hours.
  - Infants and children up to 12 years of age—Use is not recommended .

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.

Precautions While Using Efidac 24 Pseudoephedrine

If symptoms do not improve within 7 days or if you also have a high fever, check with your doctor since these signs may mean that you have other medical problems.

Efidac 24 Pseudoephedrine 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 as soon as possible if any of the following side effects occur:

Rare - more common with high doses

Convulsions (seizures)

hallucinations (seeing, hearing, or feeling things that are not there)

irregular or slow heartbeat

shortness of breath or troubled breathing

Symptoms of overdose

Convulsions (seizures)

fast breathing

hallucinations (seeing, hearing, or feeling things that are not there)

increase in blood pressure

irregular heartbeat (continuing)

shortness of breath or troubled breathing (severe or continuing)

slow or fast heartbeat (severe or continuing)

unusual nervousness, restlessness, or excitement

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

Nervousness

restlessness

trouble in sleeping

Less common

Difficult or painful urination

dizziness or light-headedness

fast or pounding heartbeat

headache

increased sweating

nausea or vomiting

trembling

unusual paleness

weakness

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

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

See also: Efidac 24 Pseudoephedrine 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 Efidac 24 Pseudoephedrine resources

Efidac 24 Pseudoephedrine Side Effects (in more detail)
Efidac 24 Pseudoephedrine Use in Pregnancy & Breastfeeding
Drug Images
Efidac 24 Pseudoephedrine Drug Interactions
Efidac 24 Pseudoephedrine Support Group
8 Reviews for Efidac 24 Pseudoephedrine - Add your own review/rating

Compare Efidac 24 Pseudoephedrine with other medications

Nasal Congestion

Abelcet (Cephalon (UK) Limited)

1. Name Of The Medicinal Product

Abelcet 5mg/mL Concentrate for Suspension for Infusion

2. Qualitative And Quantitative Composition

Amphotericin B Lipid Complex. Each vial contains 5mg Amphotericin B per mL.

Excipients:

Contains 3.6 mg/mL of sodium (0.156 mmol); this represents 71.8 mg of sodium (3.12 mmol) per 20 mL vial.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Concentrate for suspension for infusion

4. Clinical Particulars

4.1 Therapeutic Indications

Abelcet is indicated for the treatment of severe invasive candidiasis.

Abelcet is also indicated as second line therapy for the treatment of severe systemic fungal infections in patients who have not responded to conventional amphotericin B or other systemic antifungal agents, in those who have renal impairment or other contra-indications to conventional amphotericin B, or in patients who have developed amphotericin B nephrotoxicity. Abelcet treatment is indicated as second line treatment for invasive aspergillosis, cryptococcal meningitis and disseminated cryptococcosis in HIV patients, fusariosis, coccidiomycosis, zygomycosis and blastomycosis.

4.2 Posology And Method Of Administration

Abelcet is a sterile, pyrogen-free suspension which must be diluted for intravenous infusion only.

Abelcet should be administered by intravenous infusion at 5 mg/kg at a rate of 2.5 mg/kg/hr.

When commencing treatment with Abelcet for the first time it is recommended to administer a test dose immediately prior to the first infusion. The first infusion should be prepared according to the instructions then, over a period of approximately 15 minutes, 1mg of the infusion should be administered to the patient. After this amount has been administered the infusion should be stopped and the patient observed carefully for 30 minutes. If the patient shows no signs of hypersensitivity the infusion may be continued. As for use with all amphotericin B products, facilities for cardiopulmonary resuscitation should be readily at hand when administering Abelcet for the first time, due to the possible occurrence of anaphylactoid reactions.

For severe systemic infections treatment is generally recommended for at least 14 days.

Abelcet has been administered for as long as 28 months, and cumulative doses have been as high as 73.6 g without significant toxicity.

An in-line filter may be used for intravenous infusion of Abelcet. The mean pore diameter of the filter should be no less than 15 microns.

Use in diabetic patients

Abelcet may be administered to diabetic patients.

Use in paediatric patients

Systemic fungal infections have been treated successfully in children ranging from 1 month to 16 years of age at doses comparable to the recommended adult dose on a bodyweight basis. Adverse events seen in paediatric patients are similar to those seen in adults.

Use in elderly patients

Systemic fungal infections in elderly patients have been treated successfully with Abelcet at doses comparable to the recommended dose on a bodyweight basis.

Use in neutropenic patients

Abelcet has been used successfully to treat systemic fungal infections in patients who are severely neutropenic as a consequence of haematological malignancy or the use of cytotoxic or immunosuppressive drugs.

Use in patients with renal or liver disease

Systemic fungal infections in patients with renal or liver disease have been treated successfully with Abelcet at doses comparable to the recommended dose on a body weight basis (see section 4.4).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients , unless in the opinion of the physician the advantages of using Abelcet outweigh the risks of hypersensitivity.

4.4 Special Warnings And Precautions For Use

In patients for whom sodium intake is of medical concern (e.g. patients with congestive heart failure, renal failure, nephrotic syndrome), the sodium content of this product should be taken into account (see section 2).

Infusion Hypersensitivity Reactions

Infusion related reactions (such as chills and pyrexia) recorded following the administration of Abelcet have generally been mild or moderate, and have mainly be recorded during the first 2 days of administration (see section 4.8).

Premedication (e.g. paracetamol) may be administered for the prevention of infusion related adverse reactions.

Systemic Fungal Infections

Abelcet should not be used for treating common or superficial, clinically inapparent fungal infections that are detectable only by positive skin or serologic tests.

Patients with renal Disease

Since Abelcet is a potentially nephrotoxic drug, monitoring of renal function should be performed before initiating treatment in patients with pre-existing renal disease or who have already experienced renal failure, and at least once weekly during therapy. Abelcet can be administered to patients during renal dialysis or haemofiltration. Serum potassium and magnesium levels should be monitored regularly.

Patients with liver Disease

Patients with concurrent hepatic impairment due to infection, graft-versus-host disease, other liver disease or administration of hepatotoxic drugs have been successfully treated with Abelcet. In cases where serum bilirubin, alkaline phosphatase or serum transaminases increased, factors other than Abelcet were present and possibly accounted for the abnormalities. These factors included infection, hyperalimentation, concomitant hepatotoxic drugs and graft-versus-host disease.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Nephrotoxic Drugs

Abelcet is a potentially nephrotoxic drug, and particularly close monitoring of renal function is required in patients receiving nephrotoxic drugs concomitantly.

Zidovudine

In dogs, exacerbated myelotoxicity and nephrotoxicity were observed when Abelcet was administered concomitantly with zidovudine. If concomitant treatment with zidovudine is required, renal and haematologic function should be closely monitored.

Cyclosporin

Interaction data with amphotericin B containing products indicate that patients receiving amphotericin B concomitantly with high dose cyclosporine experience an increase in serum creatinine caused by simultaneous administration of these two compounds. However, Abelcet has been shown to be less nephrotoxic than conventional amphotericin B.

Other drugs

The interaction of Abelcet with other drugs has not been studied to date. Conventional amphotericin B has been reported to interact with the following drugs, and caution should be exercised during concomitant use with Abelcet: antineoplastic agents, corticosteroids and corticotrophin (ACTH), digitalis glycosides, flucytosine, and skeletal muscle relaxants.

Leukocyte transfusions

Acute pulmonary toxicity has been reported in patients receiving intravenous conventional amphotericin B and leukocyte transfusions. It is not recommended to administer Abelcet with leukocyte transfusions.

4.6 Pregnancy And Lactation

Conventional amphotericin B has been used successfully to treat systemic fungal infections in pregnant women with no obvious effects on the foetus, but only a small number of cases have been reported. Reproductive toxicity studies of Abelcet in rats and rabbits showed no evidence of embryotoxicity, foetotoxicity or teratogenicity. However, safety for use in pregnant women has not been established for Abelcet. Abelcet should only be administered to pregnant women when the likely benefit exceeds the risk to the mother and foetus.

It is unknown whether Abelcet passes into breast milk. A decision on whether to continue/discontinue nursing or whether to continue/discontinue Abelcet should be made taking into account the benefit of breast-feeding to the child and the benefit of Abelcet to the woman.

4.7 Effects On Ability To Drive And Use Machines

The effects of Abelcet on the ability to drive and /or use machines have not been investigated. Some of the undesirable effects of Abelcet presented below may impact the ability to drive and use machines. However, the clinical condition of patients who require Abelcet generally precludes driving or operating machinery.

4.8 Undesirable Effects

The most common clinical adverse reactions in randomised controlled and open label clinical trials have been chills (16%), increased creatinine (13%), pyrexia (10%), hypokalaemia (9%), nausea (7%) and vomiting (6%)..

The incidence is based on analysis from pooled clinical trials of 709 Abelcet treated patients.

There were 556 cases in emergency use studies (open-label, non comparative studies) and 153 in a randomised controlled trial in invasive candidiasis (38%

The following adverse reactions have been reported with Abelcet during clinical trials and/or post-marketing use.

Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (

System organ class	Adverse reaction	Frequency
Blood and lymphatic system disorders
	Thrombocytopenia	Common
Immune system disorders
	Anaphylactic response	Uncommon
Metabolism and nutrition disorders
	Hyperbilirubinaemia, Hypokalaemia, Electrolyte imbalance including blood potassium increased, blood magnesium decreased	Common
Nervous system disorders
	Headache, Tremor	Common
	Convulsion, Neuropathy	Uncommon
	Encephalopathy	Not known
Cardiac disorders
	Tachycardia, Cardiac Arrhythmias	Common
	Cardiac arrest	Uncommon
Vascular disorders
	Hypertension, Hypotension	Common
	Shock	Uncommon
Respiratory, thoracic and mediastinal disorders
	Dyspnoea, Asthma	Common
	Respiratory failure	Uncommon
	Bronchospasm	Not known
Gastrointestinal disorders
	Nausea, Vomiting, Abdominal pain	Common
Hepatobiliary disorders
	Liver function tests abnormal	Common
Skin and subcutaneous tissue disorders
	Rash	Common
	Pruritus	Uncommon
	Dermatitis exfoliative	Not known
Musculoskeletal and connective tissue disorders
	Myalgia	Uncommon
Renal and urinary disorders
	Renal impairment including renal failure	Common
	Hyposthenuria, Renal tubular acidosis	Not known
General disorders and administration site conditions
	Chills, Pyrexia	Very common
	Injection site reaction	Uncommon
Investigations
	Blood creatinine increased	Very common
	Blood alkaline phosphatase increased, blood urea increased	Common

The undesirable effects listed with frequency “not known” (encephalopathy, bronchospasm, dermatitis exfoliative, hyposthenuria, renal tubular acidosis) have been observed during post-marketing use.

Adverse reactions that have been reported to occur with conventional amphotericin B may occur with Abelcet. In general, the physician should monitor the patient for any type of adverse event associated with conventional amphotericin B.

Infusion hypersensitivity reactions have been associated with abdominal pain, nausea, vomiting, myalgia, pruritus, maculopapular rash, fever, hypotension, shock, bronchospasm, respiratory failure (see section 4.4).

Patients in whom significant renal toxicity was observed following conventional amphotericin B frequently did not experience similar effects when Abelcet was substituted.

Declines in renal function, shown by increased serum creatinine and hypokalaemia, have not typically required discontinuation of treatment.

Renal tubular acidosis has been reported including hyposthenuria and electrolyte imbalance such as increased potassium and decreased magnesium.

Abnormal liver function tests have been reported with Abelcet and other amphotericin B products. Although other factors such as infection, hyperalimentation, concomitant hepatotoxic drugs and graft-versus-host disease may be contributory, a causal relationship with Abelcet cannot be excluded. Patients with abnormal liver function tests should be carefully monitored and cessation of treatment considered if liver function deteriorates.

Undesirable effects observed in children are similar to those observed in adults.

In elderly patients, the adverse reaction profile was similar to that seen in adults less than 65 years. Important exceptions were increases in serum creatinine and dyspnoea which were reported in elderly patients for both Abelcet and conventional amphotericin B with a greater frequency in this age group.

4.9 Overdose

Dosages up to 10mg/kg/day have been administered in clinical studies with no apparent dose-dependent toxicity.

Instances of overdose reported with Abelcet have been consistent with those reported in clinical trials with treatment at standard doses (see section 4.8). In addition, seizures and bradycardia were experienced by one paediatric patient who received a dose of 25mg/kg.

In case of overdose, the status of the patient (in particular the cardio-pulmonary, renal and hepatic function as well as the blood count and serum electrolytes) should be monitored and supportive measures initiated. No specific antidote to amphotericin B is known.

5. Pharmacological Properties

Abelcet consists of the antifungal agent, amphotericin B, complexed to two phospholipids. Amphotericin B is a macrocyclic, polyene, broad-spectrum antifungal antibiotic produced by Streptomyces nodosus. The lipophilic moiety of amphotericin B allows molecules of the drug to be complexed in a ribbon-like structure with the phospholipids.

5.1 Pharmacodynamic Properties

ATC Code

J02A A01

Mechanism of action

Amphotericin B, the active antifungal agent in Abelcet, may be fungistatic or fungicidal, depending on its concentration and on fungal susceptibility. The drug probably acts by binding to ergosterol in the fungal cell membrane causing subsequent membrane damage. As a result, cell contents leak from the fungal cell, and, ultimately, cell death occurs. Binding of the drug to sterols in human cell membranes may result in toxicity, although amphotericin B has greater affinity for fungal ergosterol than for the cholesterol of human cells.

Microbiological activity

Amphotericin B is active against many fungal pathogens in vitro, including Candida spp., Cryptococcus neoformans, Aspergillus spp., Mucor spp., Sporothrix schenckii, Blastomyces dermatitidis, Coccidioides immitis and Histoplasma capsulatum. Most strains are inhibited by amphotericin B concentrations of 0.03-1.0 μg/ml. Amphotericin B has little or no activity against bacteria or viruses. The activity of Abelcet against fungal pathogens in vitro is comparable to that of amphotericin B. However, activity of Abelcet in vitro may not predict activity in the infected host.

5.2 Pharmacokinetic Properties

Amphotericin B is complexed to phospholipids in Abelcet. The pharmacokinetic properties of Abelcet and conventional amphotericin B are different. Pharmacokinetic studies in animals showed that, after administration of Abelcet, amphotericin B levels were highest in the liver, spleen and lung. Amphotericin B in Abelcet was rapidly distributed to tissues. The ratio of drug concentrations in tissues to those in blood increased disproportionately with increasing dose, suggesting that elimination of the drug from the tissues was delayed. Peak blood levels of amphotericin B were lower after administration of Abelcet than after administration of equivalent amounts of conventional drug. Administration of conventional amphotericin B resulted in much lower tissue levels than did dosing with Abelcet. However, in dogs, conventional amphotericin B produced 20-fold higher kidney concentrations than did Abelcet given at comparable doses.

The pharmacokinetics of Abelcet in whole blood were determined in patients with mucocutaneous leishmaniasis. Results for mean pharmacokinetic parameters at 5.0 mg/kg/day were as follows:

	Abelcet
Dose: (mg/kg/day)	5.0
Peak blood level C_max : (μg/ml)	1.7
Area under time-concentration curve AUC_0-24: (μg.hr/ml)	9.5
Clearance: (ml/hr.kg)	211.0
Volume of distribution Vd: (l/kg)	2286.0
Half-life T_½ : (hr)	173.4

The rapid clearance and large volume of distribution of Abelcet result in a relatively low AUC and are consistent with preclinical data showing high tissue concentrations. The kinetics of Abelcet are linear, the AUC increases proportionately with dose.

Details of the tissue distribution and metabolism of Abelcet in humans, and the mechanisms responsible for reduced toxicity, are not well understood. The following data are available from necropsy in a heart transplant patient who received Abelcet at a dose of 5.3 mg/kg for 3 consecutive days immediately before death:

	Organ	Abelcet tissue concentration expressed as amphotericin B content (mg/kg)
	Spleen	290.0
	Lung	222.0
	Liver	196.0
	Kidney	6.9
	Lymph node	7.6
	Heart	5.0
	Brain	1.6

5.3 Preclinical Safety Data

Acute toxicity studies in rodents showed that Abelcet was 10-fold to 20-fold less toxic than conventional amphotericin B. Multiple-dose toxicity studies in dogs lasting 2-4 weeks showed that on a mg/kg basis, Abelcet was 8-fold to 10-fold less nephrotoxic than conventional amphotericin B. This decreased nephrotoxicity was presumably a result of lower drug concentrations in the kidney.

Since conventional amphotericin B first became available, there have been no reports of drug-related carcinogenicity, mutagenicity, teratogenicity or adverse effect on fertility. Abelcet has been shown not to be mutagenic by the in vivo mouse micronucleus assay, in vitro bacterial and lymphoma mutation assays, and an in vivo cytogenetic assay. It has been shown not to be teratogenic in mice and rabbits.

Phospholipids are essential constituents of human cell membranes. The average diet provides several grams of phospholipids each day. There is no evidence that phospholipids, including DMPC and DMPG, are carcinogenic, mutagenic or teratogenic.

6. Pharmaceutical Particulars

6.1 List Of Excipients

L-α-dimyristoylphosphatidylcholine (DMPC)

L-α-dimyristoylphosphatidylglycerol (sodium and ammonium salts) (DMPG)

Sodium Chloride

Water for Injection

6.2 Incompatibilities

Abelcet should not be mixed with other drugs or electrolytes.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store at 2 - 8°C. Do not freeze. Keep vial in the outer carton.

6.5 Nature And Contents Of Container

Abelcet is a sterile, pyrogen-free yellow suspension in a type I glass single use vial containing 10 or 20 ml (50 mg or 100 mg amphotericin B). The vial is sealed with a rubber stopper and aluminum seal. Vials are packaged in cartons of 10 vials. Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Abelcet is a sterile, pyrogen-free suspension to be diluted for intravenous infusion only.

Preparation of the suspension for infusion

ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF Abelcet, SINCE NO BACTERIOSTATIC AGENT OR PRESERVATIVE IS PRESENT.

Allow the suspension to come to room temperature. Shake gently until there is no evidence of any yellow settlement at the bottom of the vial. Withdraw the appropriate dose of Abelcet from the required number of vials into one or more sterile 20 ml syringes using a 17 to 19 gauge needle. Remove the needle from each syringe filled with Abelcet and replace with the 5 micron high flow filter needle (supplied by B. Braun Medical, Inc.) provided with each vial. Insert the filter needle of the syringe into an IV bag containing 5.0% Dextrose for Injection and empty the contents of the syringe into the bag using either manual pressure or an infusion pump. The final infusion concentration should be 1 mg/ml. For paediatric patients and patients with cardiovascular disease the drug may be diluted with 5.0% Dextrose for Injection to a final infusion concentration of 2 mg/ml. Do not use the agent after dilution with 5.0% Dextrose for Injection if there is any evidence of foreign matter. Vials are single use. Unused material should be discarded. The infusion is best administered by means of an infusion pump.

DO NOT DILUTE WITH SALINE SOLUTIONS OR MIX WITH OTHER DRUGS OR ELECTROLYTES. The compatibility of Abelcet with these materials has not been established. An existing intravenous line should be flushed with 5.0% Dextrose for Injection before infusion of Abelcet or a separate infusion line should be used.

The diluted ready for use suspension may be stored at 2°C - 8°C for up to 24 hours prior to use. Shake vigorously before use. Do not store for later use.

7. Marketing Authorisation Holder

Cephalon UK Limited

1 Albany Place

Hyde Way

Welwyn Garden City

Hertfordshire

AL7 3BT

8. Marketing Authorisation Number(S)

PL: 16260/0015

9. Date Of First Authorisation/Renewal Of The Authorisation

22^nd March 2010

10. Date Of Revision Of The Text

29^th June 2010

Saturday, 31 March 2012

Cytra-2 Oral Solution

Cytra-2

INACTIVE INGREDIENTS:

Cytra-2 Oral Solution - Clinical Pharmacology

Indications and Usage for Cytra-2 Oral Solution

Contraindications

Precautions

Adverse Reactions

Overdosage

Cytra-2 Oral Solution Dosage and Administration

How is Cytra-2 Oral Solution Supplied

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Thursday, 29 March 2012

Pup Teeth

Monday, 19 March 2012

Valacyclovir Hydrochloride

Introduction

Uses for Valacyclovir Hydrochloride

Genital Herpes

Herpes Labialis

Mucocutaneous Herpes Simplex Virus (HSV) Infections

Herpes Zoster

Prevention of Cytomegalovirus (CMV) Disease in Transplant Recipients

Valacyclovir Hydrochloride Dosage and Administration

Administration

Oral Administration

Dosage

Pediatric Patients

Genital Herpes, Herpes Labialis, Mucocutaneous Herpes Simplex Virus (HSV) Infections, and Herpes Zoster

Oral

Adults

Genital Herpes

Treatment of First Episodes

Episodic Treatment of Recurrent Episodes

Suppressive Therapy of Recurrent Episodes

Reduction of Transmission

Herpes Labialis

Oral

Mucocutaneous Herpes Simplex Virus (HSV) Infections

Chronic Suppression of Recurrent Episodes

Herpes Zoster

Oral

Special Populations

Hepatic Impairment

Renal Impairment

Genital Herpes

Oral

Herpes Labialis

Oral

Herpes Zoster

Oral

Hemodialysis

Peritoneal Dialysis

Geriatric Patients

Cautions for Valacyclovir Hydrochloride

Contraindications

Warnings/Precautions

Warnings

Hematologic Effects

General Precautions

Renal Effects

CNS Effects

Genital Herpes

Herpes Labialis

Herpes Zoster

Specific Populations

Pregnancy

Lactation

Pediatric Use

Geriatric Use

Renal Impairment

Common Adverse Effects

Interactions for Valacyclovir Hydrochloride

Specific Drugs

Valacyclovir Hydrochloride Pharmacokinetics

Absorption