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Tuesday, 7 August 2012

Clindamycin Vaginal Cream

Generic Name: clindamycin phosphate

Dosage Form: vaginal cream
CLINDAMYCIN PHOSPHATE VAGINAL CREAM USP, 2%

Rx only

FOR INTRAVAGINAL USE ONLY

NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE

Clindamycin Vaginal Cream Description

Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). It has a molecular weight of 504.96, and the molecular formula is C18H34ClN2O8 PS. The structural formula is represented below:

Clindamycin phosphate vaginal cream 2%, is a semi-solid, white cream, which contains 2% clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin per gram. The pH of the cream is between 3.0 and 6.0. The cream also contains benzyl alcohol, cetostearyl alcohol, cetyl palmitate, mineral oil, polysorbate 60, propylene glycol, sorbitan monostearate, and stearic acid.

Each applicatorful of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate.

Clindamycin Vaginal Cream - Clinical Pharmacology

Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered to 6 healthy female volunteers for 7 days, approximately 5% (range 0.6% to 11%) of the administered dose was absorbed systemically. The peak serum clindamycin concentration observed on the first day averaged 18 ng/mL (range 4 to 47 ng/mL) and on day 7 it averaged 25 ng/mL (range 6 to 61 ng/mL). These peak concentrations were attained approximately 10 hours post-dosing (range 4-24 hours).

Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered for 7 consecutive days to 5 women with bacterial vaginosis, absorption was slower and less variable than that observed in healthy females. Approximately 5% (range 2% to 8%) of the dose was absorbed systemically. The peak serum clindamycin concentration observed on the first day averaged 13 ng/mL (range 6 to 34 ng/mL) and on day 7 it averaged 16 ng/mL (range 7 to 26 ng/mL). These peak concentrations were attained approximately 14 hours post-dosing (range 4-24 hours).

There was little or no systemic accumulation of clindamycin after repeated vaginal dosing of clindamycin phosphate vaginal cream 2%. The systemic half-life was 1.5 to 2.6 hours.

MICROBIOLOGY

Clindamycin inhibits bacterial protein synthesis at the level of the bacterial ribosome. The antibiotic binds preferentially to the 50S ribosomal subunit and affects the process of peptide chain initiation. Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis. (See INDICATIONS AND USAGE.) Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens, Gardnerella vaginalis, Mobiluncus spp., or Mycoplasma hominis, has not been defined. Nonetheless, clindamycin is an antimicrobial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:

Bacteroides spp.	Mycoplasma hominis
Peptostreptococcus spp.	Gardnerella vaginalis
Mobiluncus spp.

Indications and Usage for Clindamycin Vaginal Cream

Clindamycin phosphate vaginal cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). Clindamycin phosphate vaginal cream 2%, can be used to treat non-pregnant women and pregnant women during the second and third trimester. (See CLINICAL STUDIES.)

NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.

Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.

Contraindications

Clindamycin phosphate vaginal cream 2%, is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream. Clindamycin phosphate vaginal cream 2%, is also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.

Warnings

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of orally and parenterally administered clindamycin, as well as with topical (dermal) formulations of clindamycin. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of clindamycin, even when administered by the vaginal route, because approximately 5% of the clindamycin dose is systemically absorbed from the vagina.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated′′ colitis.

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.

Precautions

General

Clindamycin phosphate vaginal cream 2%, contains ingredients that will cause burning and irritation of the eye. In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water.

The use of clindamycin phosphate vaginal cream 2% may result in the overgrowth of nonsusceptible organisms in the vagina. In clinical studies involving 600 non-pregnant women who received treatment for 3 days, Candida albicans was detected, either symptomatically or by culture, in 8.8% of patients. In 9% of the patients, vaginitis was recorded. In clinical studies involving 1325 non-pregnant women who received treatment for 7 days, Candida albicans was detected, either symptomatically or by culture, in 10.5% of patients. Vaginitis was recorded in 10.7% of the patients. In 180 pregnant women who received treatment for 7 days, Candida albicans was detected, either symptomatically or by culture, in 13.3% of patients. In 7.2% of the patients, vaginitis was recorded. Candida albicans, as reported here, includes the terms: vaginal moniliasis and moniliasis (body as a whole). Vaginitis includes the terms: vulvo-vaginal disorder, vulvovaginitis, vaginal discharge, trichomonal vaginitis, and vaginitis.

Information for the Patient:

The patient should be instructed not to engage in vaginal intercourse, or use other vaginal products (such as tampons or douches) during treatment with this product.

The patient should also be advised that this cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, use of such products within 72 hours following treatment with clindamycin phosphate vaginal cream 2%, is not recommended.

Drug Interactions

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential. Genotoxicity tests performed included a rat micronucleus test and an Ames test. Both tests were negative. Fertility studies in rats treated orally with up to 300 mg/kg/day (31 times the human exposure based on mg/m2 ) revealed no effects on fertility or mating ability.

Pregnancy: Teratogenic effects

Pregnancy Category B

There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. This drug should be used during the first trimester of pregnancy only if clearly needed.

Clindamycin phosphate vaginal cream 2% has been studied in pregnant women during the second trimester. In women treated for seven days, abnormal labor was reported in 1.1% of patients who received Clindamycin Vaginal Cream 2% compared with 0.5% of patients who received placebo.

Reproduction studies have been performed in rats and mice using oral and parenteral doses of clindamycin up to 600 mg/kg/day (62 and 25 times, respectively, the maximum human exposure based on mg/m2 ) and have revealed no evidence of harm to the fetus due to clindamycin. In one mouse strain, cleft palates were observed in treated fetuses; this outcome was not produced in other mouse strains or in other species and is, therefore, considered to be a strain specific effect.

See INDICATIONS AND USAGE; PRECAUTIONS, General; and ADVERSE REACTIONS.

Nursing Mothers

Clindamycin has been detected in human milk after oral or parenteral administration. It is not known if clindamycin is excreted in human milk following the use of vaginally administered clindamycin phosphate.

Because of the potential for serious adverse reactions in nursing infants from clindamycin phosphate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

Clinical studies for clindamycin phosphate vaginal cream 2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Adverse Reactions

Clinical trials

Non-pregnant Women: In clinical trials involving non-pregnant women, 1.8% of 600 patients who received treatment with clindamycin phosphate vaginal cream 2% for 3 days and 2.7% of 1325 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 20.7% of the patients receiving treatment for 3 days and 21.3% of the patients receiving treatment for 7 days. Events occurring in ≥1% of patients receiving clindamycin phosphate vaginal cream 2% are shown in Table 1.

Events Occuring in ≥ 1% of Non-pregnant Patients Receiving Clindamycin Phosphate Vaginal Cream 2%

Other events occurring in <1% of the Clindamycin Vaginal Cream 2% groups include:

Urogenital system: vaginal discharge, metrorrhagia, urinary tract infection, endometriosis, menstrual disorder, vaginitis/vaginal infection, and vaginal pain.

Body as a whole: localized abdominal pain, generalized abdominal pain, abdominal cramps, halitosis, headache, bacterial infection, inflammatory swelling, allergic reaction, and fungal infection.

Digestive system: nausea, vomiting, constipation, dyspepsia, flatulence, diarrhea, and gastrointestinal disorder.

Endocrine system: hyperthyroidism.

Central nervous system: dizziness and vertigo.

Respiratory system: epistaxis.

Skin: pruritus (non-application site), moniliasis, rash, maculopapular rash, erythema, and urticaria.

Special senses: taste perversion.

Pregnant Women: In a clinical trial involving pregnant women during the second trimester, 1.7% of 180 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 22.8% of pregnant patients. Events occurring in ≥1% of patients receiving either clindamycin phosphate vaginal cream 2% or placebo are shown in Table 2.

Events Occuring in ≥ 1% of Pregnant Patients Receiving Clindamycin Phosphate Vaginal Cream 2% or Placebo

Other events occurring in <1% of the Clindamycin Vaginal Cream 2% group include:

Urogenital system: dysuria, metrorrhagia, vaginal pain, and trichomonal vaginitis.

Body as a whole: upper respiratory infection.

Skin: pruritus (topical application site) and erythema.

Other clindamycin formulations:

Clindamycin Vaginal Cream affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to 100 mg oral clindamycin dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral clindamycin, the possibility of these and other reactions cannot be excluded presently. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available.

The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin:

Gastrointestinal: Abdominal pain, esophagitis, nausea, vomiting, and diarrhea. (See WARNINGS.)

Hematopoietic: Transient neutropenia (leukopenia), eosinophilia, agranulocytosis, and thrombocytopenia have been reported. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of these reports.

Hypersensitivity Reactions: Maculopapular rash and urticaria have been observed during drug therapy. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions. Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported. If a hypersensitivity reaction occurs, the drug should be discontinued.

Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.

Musculoskeletal: Rare instances of polyarthritis have been reported.

Renal: Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed in rare instances.

Overdosage

Vaginally applied clindamycin phosphate vaginal cream 2% could be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS.)

Clindamycin Vaginal Cream Dosage and Administration

The recommended dose is one applicatorful of clindamycin phosphate vaginal cream 2%, (5 grams containing approximately 100 mg of clindamycin phosphate) intravaginally, preferably at bedtime, for 3 or 7 consecutive days in non-pregnant patients and for 7 consecutive days in pregnant patients. (See CLINICAL STUDIES.)

How is Clindamycin Vaginal Cream Supplied

Clindamycin Phosphate Vaginal Cream 2% (clindamycin phosphate vaginal cream) is a white to off-white cream having a slight odor and is supplied as follows:

40 g tube (with 7 disposable applicators) NDC 0168-0277-40

Store at 20° to 25°C (68° to 77° F)[see USP Controlled Room Temperature].

Clinical Studies

In two clinical studies involving 674 evaluable non-pregnant women with bacterial vaginosis comparing clindamycin phosphate vaginal cream 2% for 3 or 7 days, the clinical cure rates, determined at 1 month posttherapy, ranged from 72% to 81% for the 3-day treatment and 84% to 86% for the 7-day treatment.

	Clindamycin Phosphate 3 Day		Clindamycin Phosphate 7 Day
U.S. Study	94/131	72%	110/128	86%
European Study	161/199	81%	181/216	84%

In a clinical study involving 249 evaluable pregnant patients in the second and third trimester treated for 7 days, the clinical cure rate, determined at 1 month posttherapy, was 60% (77/129) in the clindamycin arm and 9% (11/120) for the vehicle arm. The determination of clinical cure was based on the absence of a "fishy" amine odor when the vaginal discharge was mixed with a 10% KOH solution and the absence of clue cells on microscopic examination.

E. FOUGERA & CO.

A division of Nycomed US Inc.

Melville, New York 11747

I2277

R4/08

#116

DIRECTIONS FOR USE

7 Disposable plastic applicators are provided with this package. They are designed to allow proper vaginal administration of the cream.

Remove cap from cream tube. Screw a plastic applicator on the threaded end of the tube.

Rolling tube from the bottom, squeeze gently and force the medication into the applicator.

The applicator is filled when the plunger reaches its predetermined stopping point.

Unscrew the applicator from the tube and replace the cap.

While lying on your back, firmly grasp the applicator barrel and insert into vagina as far as possible without causing discomfort.

Slowly push the plunger until it stops. Carefully withdraw applicator from vagina, and discard applicator.

REMEMBER TO APPLY ONE APPLICATORFUL EACH NIGHT BEFORE BEDTIME, OR AS PRESCRIBED BY YOUR DOCTOR.

INSTRUCCIONES PARA LA PACIENTE

Este envase contiene 7 aplicadores de plástico desechables. Los aplicadores están diseñados para la adminstración apropiada de la crema en la vagina.

Remueva la tapa del tubo de crema y enrosque el aplicador de plástico al tubo.

Exprima el tubo suavemente desde el extremo inferior y fuerce el medicamento al aplicador.

El aplicador estará lleno cuando el émbolo llega a su máxima longitud. Desenrosque el aplicador del tubo y vuelva a poner la tapa.

Acuéstese de espada y agarrando firemente el aplicador, introdúzcalo en la vagina tanto como sea posible sin causar molestias.

Empuje lentamente el émbolo hasta que se detenga.

Saque el aplicador cuidadosamente de la vagina y descártelo.

RECUERDE APLICARSE UN APLICADOR LLENO TODAS LAS NOCHES AL ACOSTARSE, O DE ACUDERDO CON LAS INDICACIONES DE SU MEDICO.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 40 GRAM TUBE

NDC 0168-0277-40

Fougera ®

CLINDAMYCIN PHOSPHATE

VAGINAL CREAM USP, 2%

equivalent to 2% clindamycin

Rx only

For Intravaginal Use Only.

Not for Ophthalmic, Dermal,

or Oral Use.

NET WT 40 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 40 GRAM CARTON

NDC 0168-0277-40

Fougera ®

CLINDAMYCIN

PHOSPHATE

VAGINAL CREAM

USP, 2%

equivalent to 2% clindamycin

For Intravaginal Use Only.

Not for Ophthalmic,

Dermal, or Oral Use.

Rx only

NET WT 40 grams

with

7 applicators

E. FOUGERA & CO.

A division of Nycomed US Inc.

Melville, New York 11747

CLINDAMYCIN PHOSPHATE
clindamycin phosphate cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0168-0277
Route of Administration	VAGINAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Clindamycin Phosphate (Clindamycin)	Clindamycin Phosphate	20 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
benzyl alcohol
cetostearyl alcohol
cetyl palmitate
mineral oil
polysorbate 60
propylene glycol
sorbitan monostearate
stearic acid
water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0168-0277-40	40 g In 1 TUBE, WITH APPLICATOR	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA065139	12/27/2004

Labeler - E. FOUGERA & CO. A division of Nycomed US Inc. (043838424)

Registrant - Nycomed US Inc. (043838424)

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		174491316	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		043838424	ANALYSIS

Revised: 08/2009E. FOUGERA & CO. A division of Nycomed US Inc.

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Monday, 6 August 2012

imipenem and cilastatin

Generic Name: imipenem and cilastatin (IM i PEN em and SYE la STAT in)

Brand names: Primaxin IM, Primaxin IV, Primaxin IV ADD-Vantage

What is imipenem and cilastatin?

Imipenem is an antibiotic that fights serious infections caused by bacteria.

Cilastatin helps imipenem work more effectively by preventing the breakdown of the antibiotic in the kidneys.

Imipenem and cilastatin is used to treat severe infections of the lower respiratory tract, skin, stomach, female reproductive organs, and other body systems.

Imipenem and cilastatin may also be used for other purposes not listed here.

What is the most important information I should know about imipenem and cilastatin?

Do not use imipenem and cilastatin if you are allergic to it, if you have heart block, or if you are allergic to lidocaine or other local anesthetics (numbing medicine).

Before using imipenem and cilastatin, tell your doctor if you have kidney disease (or if you are on dialysis), or a seizure disorder.

Also tell your doctor if you are either allergic to or are currently taking a penicillin or cephalosporin antibiotic such as Amoxil, Augmentin, Bactocill, Beepen-VK, Ceclor, Ceftin, Duricef, Dycill, Dynapen, Keflex, Ledercillin VK, Omnipen, Pen-V, Pfizerpen, Principen, Veetids, and others.

Primaxin IM (for the muscle) and Primaxin IV (for the vein) are different forms of this medicine and should be used only for their specific type of injection. Do not inject Primaxin IM into a vein and do not inject Primaxin IV into a muscle.

Call your doctor at once if you have serious side effects such as pounding heartbeats, confusion, hallucinations, seizure (convulsions), feeling light-headed, fainting, flu symptoms, nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes), or a severe blistering, peeling, and red skin rash.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

What should I discuss with my healthcare provider before use imipenem and cilastatin?

Do not use imipenem and cilastatin if you are allergic to it, if you have heart block, or if you are allergic to lidocaine or other local anesthetics (numbing medicine).

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

kidney disease (or if you are on dialysis);

epilepsy or other seizure disorder;

a history of allergy to penicillin antibiotics such as Amoxil, Augmentin, Omnipen, Principen, Dycill, Dynapen, Bactocill, Beepen-VK, Ledercillin VK, Pen-V, Pfizerpen, Veetids, and others; or

a history of allergy to cephalosporin antibiotics such as Ceclor, Ceftin, Duricef, Keflex, and others.

FDA pregnancy category C. It is not known whether imipenem and cilastatin 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 imipenem and cilastatin 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.

How should I use imipenem and cilastatin?

Imipenem and cilastatin is injected into a vein (IV) or into a muscle (IM).

Imipenem and cilastatin is usually given in a clinic or hospital setting. The IV medicine must be given as a slow infusion and can take up to an hour to complete. Tell your caregiver if you feel nauseated during the infusion. You may need to receive the medicine at a slower rate.

The IM form of imipenem and cilastatin is given as a rapid injection into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Imipenem and cilastatin is usually given as long as needed until your infection has cleared or you have been symptom-free for at least 48 hours.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Imipenem and cilastatin will not treat a viral infection such as the common cold or flu.

Do not give this medication to another person, even if they have the same symptoms you do.

Imipenem and cilastatin is a powder that must be mixed with a liquid (diluent). Primaxin IM and Primaxin IV are each mixed with different types of diluent.

Prepare your dose in a syringe only when you are ready to give yourself an injection.

After mixing Primaxin IV, you may keep it in a refrigerator and use it within 24 hours. You may also store the mixed IV medicine at room temperature if you use it within 4 hours. Store unmixed imipenem and cilastatin powder at room temperature away from moisture and heat.

What happens if I miss a dose?

If imipenem and cilastatin is given in a hospital setting, it is not likely that you will miss a dose. If you are using the medication at home and you miss a dose, give the injection as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include weakness, drooping eyelid, tremors, trouble breathing, or seizure (black-out or convulsions).

What should I avoid while using imipenem and cilastatin?

Imipenem and cilastatin 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. Call your doctor at once if you have a serious side effect such as:

fast or pounding heartbeats;

diarrhea that is watery or bloody;

confusion, tremors, hallucinations, seizure (convulsions);

feeling light-headed, fainting;

fever, chills, body aches, flu symptoms;

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

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

Less serious side effects may include:

pain, swelling, or redness where the medicine was injected;

mild nausea, vomiting, heartburn, or stomach pain;

sore throat;

vaginal itching or discharge;

mild skin rash or itching;

dizziness or tired feeling;

numbness or tingling; or

ringing in your ears.

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.

Imipenem and cilastatin Dosing Information

Usual Adult Dose for Aspiration Pneumonia:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: Parenteral therapy should be continued until the patient's clinical condition stabilizes and fever subsides. Oral antibiotic therapy may then be initiated according to microbiologic sensitivity data. Therapy of documented anaerobic pleuropulmonary infections should be continued until the infiltrate is cleared or a residual scar forms, sometimes requiring 2 to 4 months.

Usual Adult Dose for Bacteremia:

500 mg IV every 6 hours or 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Septicemia:

Usual Adult Dose for Bronchitis:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less

IM:
Mild to moderate infections: 500 to 750 mg IM every 12 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 1500 mg/day

Usual Adult Dose for Pelvic Infections:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less

IM:
Mild to moderate infections: 500 to 750 mg IM every 12 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 1500 mg/day

Usual Adult Dose for Endometritis:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less

IM:
Mild to moderate infections: 500 to 750 mg IM every 12 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 1500 mg/day

Usual Adult Dose for Deep Neck Infection:

Usual Adult Dose for Endocarditis:

Usual Adult Dose for Febrile Neutropenia:

500 mg IV every 6 hours if suspected causative organism is fully susceptible, 1 g IV every 8 hours if other suspected causative organisms are moderately susceptible, or 1 g IV every 6 hours if Pseudomonas aeruginosa is suspected causative organism (based on imipenem content)
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: Once the patient is stable and afebrile for at least 24 hours, and the absolute neutrophil count is at least 500 cells/mm3, oral antimicrobial therapy, based on susceptibility patterns, may be initiated. Then duration of therapy is dependent on the clinical situation.

Usual Adult Dose for Intraabdominal Infection:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 7 to 14 days, depending on the nature and severity of the infection

IM:
Mild to moderate infections: 750 mg IM every 12 hours
Maximum dose: 1500 mg/day

Usual Adult Dose for Joint Infection:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 3 to 4 weeks, depending on the nature and severity of the infection
Longer therapy, 6 weeks or more, may be required for prosthetic joint infections.

Usual Adult Dose for Meningitis:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 14 days, depending on the nature and severity of the infection
Treatment of meningitis due to Listeria species should be continued for 3 to 6 weeks.

Usual Adult Dose for Nosocomial Pneumonia:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Initial empiric treatment with broad-spectrum coverage according to the hospital's and/or ICU's antibiogram is recommended if multidrug-resistant organisms are suspected.

Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: If the causative organism is not Pseudomonas aeruginosa, the duration of treatment should be as short as clinically possible (e.g., as little as 7 days) to reduce the risk of superinfections with resistant organisms.

Usual Adult Dose for Osteomyelitis:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 4 to 6 weeks, depending on the nature and severity of the infection
Chronic osteomyelitis may require additional oral antimicrobial therapy, possibly for up to 6 months. Surgical debridement of devitalized bone is also critical.

Usual Adult Dose for Peritonitis:

Usual Adult Dose for Pneumonia:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 7 days if pneumococcal pneumonia is suspected and up to 21 days for other infecting organisms, depending on the nature and severity of the infection

IM:
Mild to moderate infections: 500 to 750 mg IM every 12 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 1500 mg/day

Usual Adult Dose for Pyelonephritis:

Usual Adult Dose for Skin or Soft Tissue Infection:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 7 to 10 days, or for 3 days after acute inflammation resolves, depending on the nature and severity of the infection
For more severe infections, such as diabetic soft tissue infections, 14 to 21 days of therapy may be required.

IM:
Mild to moderate infections: 500 to 750 mg IM every 12 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 1500 mg/day

Usual Adult Dose for Skin and Structure Infection:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 7 to 10 days, or for 3 days after acute inflammation resolves, depending on the nature and severity of the infection
For more severe infections, such as diabetic soft tissue infections, 14 to 21 days of therapy may be required.

IM:
Mild to moderate infections: 500 to 750 mg IM every 12 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 1500 mg/day

Usual Adult Dose for Urinary Tract Infection:

Uncomplicated: 250 mg IV every 6 hours (based on imipenem content)
Complicated: 500 mg IV every 6 hours (based on imipenem content)

Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 3 to 7 days, depending on the nature and severity of the infection

Usual Pediatric Dose for Bacteremia:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Endocarditis:

Usual Pediatric Dose for Intraabdominal Infection:

Usual Pediatric Dose for Joint Infection:

Usual Pediatric Dose for Osteomyelitis:

Usual Pediatric Dose for Peritonitis:

Usual Pediatric Dose for Pneumonia:

Usual Pediatric Dose for Pyelonephritis:

Usual Pediatric Dose for Septicemia:

Usual Pediatric Dose for Bacterial Infection:

Usual Pediatric Dose for Urinary Tract Infection:

Usual Pediatric Dose for Skin and Structure Infection:

Usual Pediatric Dose for Bronchitis:

Usual Pediatric Dose for Pelvic Infections:

Usual Pediatric Dose for Endometritis:

Usual Pediatric Dose for Pneumonia with Cystic Fibrosis:

Greater than 12 years with normal renal function: Up to 90 mg/kg/day IV in divided doses (based on imipenem content)
Maximum dose: 4 g/day

What other drugs will affect imipenem and cilastatin?

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

valproic acid (Depakene, Stavzor);

ganciclovir (Cytovene);

probenecid (Benemid);

a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin), ampicillin (Omnipen, Principen), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids, and others); or

a cephalosporin antibiotic such as cefaclor (Ceclor), cefuroxime (Ceftin), cefadroxil (Duricef), cephalexin (Keflex), and others.

This list is not complete and other drugs may interact with imipenem and cilastatin. 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 imipenem and cilastatin resources

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

Compare imipenem and cilastatin with other medications

Aspiration Pneumonia
Bacteremia
Bacterial Infection
Bone infection
Bronchitis
Deep Neck Infection
Endocarditis
Endometritis
Febrile Neutropenia
Intraabdominal Infection
Joint Infection
Kidney Infections
Meningitis
Nosocomial Pneumonia
Pelvic Infections
Peritonitis
Pneumonia
Pneumonia with Cystic Fibrosis
Septicemia
Skin and Structure Infection
Skin Infection
Urinary Tract Infection

Where can I get more information?

Your doctor or pharmacist can provide more information about imipenem and cilastatin.

Gentamicin 40mg / ml Injection (Preserved) (Hospira UK Ltd)

1. Name Of The Medicinal Product

Gentamicin 40 mg/ml Injection

2. Qualitative And Quantitative Composition

1 ml of solution for injection contains 40 mg of gentamicin (as sulphate)

1 vial of 2 ml solution for injection contains 80 mg of gentamicin (as sulphate)

For excipients, see 6.1

3. Pharmaceutical Form

Solution for injection.

Vials containing a clear colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Gentamicin is bactericidal and is active against many strains of Gram-positive and Gram-negative pathogens including species of Escherichia, Enterobacter, Klebsiella, Salmonella, Serratia, Shigella, Staphylococcus aureus, some Proteus and against Pseudomonas aeruginosa. Gentamicin is often effective against strains of these organisms which are resistant to other antibiotics such as streptomycin, kanamycin and neomycin. Gentamicin is effective against penicillin-resistant Staphylococci, but rarely effective against Streptococci.

Gentamicin is indicated in the treatment of the following infections when caused by susceptible organisms.

Severe Gram-Negative Infections:

Upper and lower urinary tract infections

Burn and wound infections

Septicaemia, Bacteraemia

Abscesses

Subacute Bacterial Endocarditis

Respiratory Tract infections (Bronchopneumonia)

Neonatal infections

Gynaecological infections

Gram-Positive Infections:

Bacteraemia

Abscesses

Accidental and operative trauma

Burns and serious skin lesions.

4.2 Posology And Method Of Administration

Gentamicin is normally given by the intramuscular route, but can be given intravenously when intramuscular administration is not feasible.

Gentamicin is normally given by the intramuscular route, but can be given intravenously when intramuscular administration is not feasible, e.g. in shocked or severely burned patients. When given intravenously, the prescribed dose should be administered slowly over 2 to 3 minutes directly into a vein or into the rubber tubing of a giving set. Rapid, direct intravenous administration may give rise, initially, to potentially neurotoxic concentrations and it is essential that the prescribed dose is administered over the recommended period of time. Alternatively the prescribed dose should be dissolved in up to 100 ml of normal saline or 5% glucose in water, but not solutions containing bicarbonate (see Incompatibilities P6B, 7h), and the solution infused over a period of 20 to 30 minutes.

The same dosage schedule is recommended for intramuscular and intravenous dosing. Dosage is related to the severity of infection, the age of the patient and the patient's renal function.

Dosage in Patients with Normal Renal Function:

Adult Dosage:

Type of infection

Dosage

Time interval between doses

Duration of therapy

Systemic and urinary tract infections

3 mg/kg/day up to 80 mg

8 hours

7-10 days

Life threatening infections

5 mg/kg/day initially then

3 mg/kg/day as soon as improvement is indicated

6-8 hours

7-10 days (longer therapy may be required. If so, auditory renal and vestibular functions should be monitored.

Paediatric Dosage:

Infection	Age	Dose/Route	Frequency
Systemic	0-7 days 1 week- 1 year 1 year- 12 years	5 mg/kg/day IM 6 mg/kg/day IM 4.5 mg/kg/day IM	12 hours 12 hours 8 hours
Urinary tract infections	-	3 mg/kg/day IM	8 hours - 12 hours
Life threatening infections	0-7 days 1 week-1 year 1 year- 12 years	5 mg/kg/day 7.5 mg/kg/day 6 mg/kg/day	12 hours 8 hours 8 hours

3. Doses in Patients with Impaired Renal Function:

Dosage is adjusted for patients with renal impairment to minimise the risk of toxicity. The first dose should be as normal - after this, doses should be given less frequently, the interval being determined by results of renal function tests as below:

Renal Function Tests:

Dose	Creatinine Clearance (ml/min)	Serum creatinine mmol/1	BUN mmol/1	Interval between doses
80 mg	over 70	less than	less than	8 hours
		0.12	6.5
	35-70	0.12-0.17	6.5-10	12 hours
	24-34	0.18-0.25	11-14	18 hours
	16-23	0.26-0.33	15-18	24 hours
	10-15	0.34-0.47	19-26	36 hours
	5-9	0.48-0.64	27-36	48 hours

Serum levels should be monitored daily.

Peak levels in infants and young children: Peak serum levels are reached in 1 hour and dosage should be adjusted to achieve levels of more than 4 micrograms/ml, but not exceed 10 micrograms/ml.

4.3 Contraindications

Patients being treated with gentamicin should be under close clinical observation because of its potential toxicity. There are no absolute contraindications other than a history of hypersensitivity to gentamicin. Gentamicin should be used with caution in premature infants because of their renal immaturity, in elderly people and generally in patients with impaired renal function. Diabetes, auditory vestibular dysfunctions, otitis media, a history of otitis media, previous use of ototoxic drugs and a genetically determined high sensitivity to aminoglycoside induced ototoxicity, are other main factors which may pre-dispose the patient to toxicity.

4.4 Special Warnings And Precautions For Use

As with other aminoglycosides toxicity is related to serum concentration. At serum levels more than 10 micrograms/ml the vestibular mechanism may be affected. Toxicity can be minimised by monitoring serum concentrations and it is advisable to check serum levels to confirm that peak levels (one hour) do not exceed 10 micrograms/ml and that trough levels (one hour before next injection) do not exceed 2 micrograms/ml. Evidence of toxicity requires adjustment of dosage or withdrawal of the drug.

Concurrent use of other neurotoxic and/or nephrotoxic drugs can increase the possibility of gentamicin toxicity. Co-administration with the following agents should be avoided:

Neuromuscular blocking agents such as succinylcholine and tubocurarine.

Other potentially nephrotoxic or ototoxic drugs such as cephalosporins and methicillin.

Potent diuretics such as ethacrynic acid and furosemide.

Other aminoglycosides.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

(i) Antibacterials: increased risk of nephrotoxicity with cephalosporins notably cephalothin .

(ii) Gentamicin has been known to potentiate anticoagulants such as warfarin and phenindione.

(iii) Antifungals: increased risk of nephrotoxicity with amphotericin.

(iv) Cholinergics: antagonism of effect of neostigmine and pyridostigmine.

(v) Cyclosporin: increased risk of nephrotoxicity.

(vi) Cytotoxics: increased risk of nephrotoxicity and possible risk of ototoxicity with cisplatin.

(vii) Diuretics: increased risk of ototoxicity with loop diuretics.

(viii) Muscle relaxants: effect of non-depolarising muscle relaxants such as tubocurarine enhanced.

4.6 Pregnancy And Lactation

Use in Pregnancy:

Although no teratogenic effects have been observed, gentamicin is known to cross the placenta. Ototoxicity in the foetus is also a potential hazard. The benefits should, therefore, be weighed against such hazards to the foetus before using gentamicin during pregnancy.

Use in Lactation:

Small amounts of gentamicin have been reported in breast milk. Because of the potential for serious adverse reactions to an aminoglycoside in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Ototoxicity and nephrotoxicity are the most common side effects associated with gentamicin therapy. Both effects are related to renal impairment and hence the dosage in such patients should be altered as suggested.

Other adverse reactions associated with gentamicin therapy include nausea, vomiting, urticaria, reversible granulocytopenia, allergic contact sensitization and neuromuscular blockade.

4.9 Overdose

As in the case of other aminoglycosides, toxicity is associated with serum levels above a critical value. In patients with normal renal function it is unlikely that toxic serum levels (in excess of 10 micrograms/ml) will be reached after administration of recommended doses. Where higher levels occur because of renal impairment, dosage should be reduced. In the event of an overdose or toxic reaction, peritoneal dialysis or haemodialysis will lower serum gentamicin levels.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Gentamicin is usually bactericidal in action. Although the exact mechanism of action has not been fully elucidated, the drug appears to inhibit protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.

In general, gentamicin is active against many aerobic gram-negative bacteria and some aerobic gram-positive bacteria. Gentamicin is inactive against fungi, viruses, and most anaerobic bacteria.

In vitro, gentamicin concentrations of 1-8 µg/ml inhibit most susceptible strains of Escherichia coli, Haemophilus influenzae, Moraxella lacunata, Neisseria, indole positive and indole negative Proteus, Pseudomonas (including most strains of Ps. aeruginosa), Staphylococcus aureus, S. epidermidis, and Serratia. However, different species and different strains of the same species may exhibit wide variations in susceptibility in vitro. In addition, in vitro susceptibility does not always correlate with in vivo activity. Gentamicin is only minimally active against Streptococci.

Natural and acquired resistance to gentamicin has been demonstrated in both gram-negative and gram-positive bacteria. Gentamicin resistance may be due to decreased permeability of the bacterial cell wall, alteration in the ribosomal binding site, or the presence of a plasmid-mediated resistance factor which is acquired by conjugation. Plasmid-mediated resistance enables the resistant bacteria to enzymatically modify the drug by acetylation, phosphorylation, or adenylylation and can be transferred between organisms of the same or different species. Resistance to other aminoglycosides and several other anti-infectives (e.g. chloramphenicol, sulphonamides, tetracycline) may be transferred on the same plasmid.

There is partial cross-resistance between gentamicin and other aminoglycosides.

5.2 Pharmacokinetic Properties

Gentamicin and other aminoglycosides are poorly absorbed from the gastro-intestinal tract but are rapidly absorbed after intramuscular injection. Average peak plasma concentrations of about 4 µg per ml have been obtained 30 to 60 minutes after intramuscular administration of a dose equivalent to 1 mg of gentamicin per kg body-weight although there may be considerable individual variation and higher concentrations in patients with renal failure. Similar concentrations are obtained after intravenous administration. Several doses are required before equilibrium concentrations are obtained in the plasma and this may represent the saturation of binding sites in body tissues such as the kidney. Binding of gentamicin to plasma proteins is usually low.

Following parenteral administration gentamicin and other aminoglycosides diffuse mainly into extracellular fluids and factors which affect the volume of distribution will also affect plasma concentrations. However, there is little diffusion into the cerebrospinal fluid and even when the meninges are inflamed effective concentrations may not be achieved; diffusion into the eye is also poor. Aminoglycosides diffuse readily into the perilymph of the inner ear. Gentamicin crosses the placenta but only small amounts have been reported in breast milk.

Systemic absorption of gentamicin and other aminoglycosides has been reported after topical use on denuded skin and burns and following instillation into and irrigation of wounds, body-cavities, and joints.

The plasma elimination half-life for gentamicin has been reported to be 2 to 3 hours though it may be considerably longer in neonates and patients with renal impairment. Gentamicin and other aminoglycosides do not appear to be metabolised and are excreted virtually unchanged in the urine by glomerular filtration. At steady-state at least 70% of a dose may be recovered in the urine 24 hours and urine concentrations in excess of 100 µg per ml may be obtained. However, gentamicin and the other aminoglycosides appear to accumulate in body tissues to some extent, mainly in the kidney, although the relative degree to which this occurs may vary with different aminoglycosides. Release from these sites is slow and aminoglycosides may be detected in the urine for up to 20 days or more after administration ceases. Small amounts of gentamicin appear in the bile.

5.3 Preclinical Safety Data

There is no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium metabisulphite

Disodium edetate

Methyl hydroxybenzoate

Propyl hydroxybenzoate

Water for Injections

Sulphuric acid (2.5N)

Sodium hydroxide (2.5N)

6.2 Incompatibilities

Gentamicin Injection should not be mixed with other drugs before injection and where co-administration of penicillins, cephalosporins, erythromycin, lipiphysan, sulphadiazine, furosemide and betalactam antibiotics and heparin is necessary, the drugs should be administered separately, either as bolus injections into the tubing of the giving set or at separate sites. Addition of gentamicin to solutions containing bicarbonate may lead to the release of carbon dioxide.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

Unused portions of opened vials must not be stored and should be discarded immediately.

6.5 Nature And Contents Of Container

80 mg/2 ml - Clear, Type I glass vials in packs of 5 vials.

6.6 Special Precautions For Disposal And Other Handling

For single use only. Discard any unused contents.

7. Marketing Authorisation Holder

Mayne Pharma Plc

Queensway

Royal Leamington Spa

Warwickshire CV31 3RW

United Kingdom

8. Marketing Authorisation Number(S)

PL 04515/0037

9. Date Of First Authorisation/Renewal Of The Authorisation

5^th February 1998

10. Date Of Revision Of The Text

2^nd April, 2003

Saturday, 4 August 2012

tetrabenazine

tet-ra-BEN-a-zeen

Oral route(Tablet)

Tetrabenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality). This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation. Tetrabenazine is contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression .

Commonly used brand name(s)

In the U.S.

Xenazine

Available Dosage Forms:

Tablet

Pharmacologic Class: Monoamine Depletor

Chemical Class: Benzoquinolizine

Uses For tetrabenazine

Tetrabenazine is used to treat chorea (a movement disorder) that is caused by Huntington disease. Tetrabenazine works in the central nervous system (CNS) to prevent the absorption of certain chemicals (such as dopamine and serotonin).

tetrabenazine is available only with your doctor's prescription.

Before Using tetrabenazine

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 tetrabenazine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tetrabenazine 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 tetrabenazine in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of tetrabenazine in geriatric patients.

Pregnancy

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

Breast Feeding

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 tetrabenazine, 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 tetrabenazine 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.

Brofaromine

Cisapride

Clorgyline

Dronedarone

Furazolidone

Iproniazid

Isocarboxazid

Lazabemide

Linezolid

Mesoridazine

Moclobemide

Nialamide

Pargyline

Phenelzine

Pimozide

Procarbazine

Rasagiline

Reserpine

Selegiline

Sparfloxacin

Toloxatone

Tranylcypromine

Using tetrabenazine 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

Ajmaline

Alfuzosin

Amiodarone

Amitriptyline

Amoxapine

Apomorphine

Arsenic Trioxide

Asenapine

Astemizole

Azimilide

Azithromycin

Bretylium

Chloroquine

Chlorpromazine

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Crizotinib

Dasatinib

Desipramine

Disopyramide

Dofetilide

Dolasetron

Droperidol

Erythromycin

Fingolimod

Flecainide

Fluconazole

Gatifloxacin

Gemifloxacin

Granisetron

Halofantrine

Haloperidol

Hydroquinidine

Ibutilide

Iloperidone

Imipramine

Lapatinib

Levofloxacin

Lopinavir

Lumefantrine

Mefloquine

Methadone

Moxifloxacin

Nilotinib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Olanzapine

Ondansetron

Paliperidone

Pazopanib

Perflutren Lipid Microsphere

Pirmenol

Posaconazole

Prajmaline

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Ranolazine

Risperidone

Salmeterol

Saquinavir

Sematilide

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Sunitinib

Tedisamil

Telavancin

Telithromycin

Terfenadine

Tetrabenazine

Thioridazine

Toremifene

Trazodone

Trifluoperazine

Trimipramine

Vandetanib

Vardenafil

Vemurafenib

Voriconazole

Ziprasidone

Using tetrabenazine 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.

Fluoxetine

Paroxetine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of tetrabenazine

Take tetrabenazine 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.

tetrabenazine may be taken with or without food.

Dosing

The dose of tetrabenazine 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 tetrabenazine. 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 form (tablets):
- For chorea:
  - Adults—At first, 12.5 milligrams (mg) in the morning once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 100 mg per day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using tetrabenazine

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to allow for changes in the dose.

Tetrabenazine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies, or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

Do not take tetrabenazine if you are also taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®). If you have questions, check with your doctor.

Do not take tetrabenazine if you are also taking reserpine (Harmonyl®). Wait at least 20 days after stopping reserpine before starting tetrabenazine. If you have questions, check with your doctor.

Check with your doctor right away if you have more than one of these symptoms while taking tetrabenazine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

tetrabenazine may cause drowsiness, trouble with thinking, or trouble with controlling movements. Make sure you know how you react to tetrabenazine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think well.

Make sure your doctor knows if you are using chlorpromazine (Thorazine®), thioridazine (Mellaril®), ziprasidone (Geodon®), moxifloxacin (Avelox®), quinidine, procainamide (Pronestyl®), amiodarone (Cordarone®), or sotalol (Betapase®). Using any of these medicines together with tetrabenazine may cause serious side effects.

tetrabenazine may cause tardive dyskinesia (a movement disorder). This may not go away after you stop using the medicine. Check with your doctor right away if you have any of the following symptoms while taking tetrabenazine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

tetrabenazine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking tetrabenazine. Check with your doctor before taking any of the above while you are using tetrabenazine.

tetrabenazine 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

Body aches or pain

chills

cough

difficulty in breathing

difficulty with swallowing

discouragement

drowsiness

ear congestion

fear or nervousness

feeling sad or empty

fever

headache

inability to sit still

irritability

lack of appetite

loss of balance control

loss of interest or pleasure

loss of voice

mask-like face

nasal congestion

need to keep moving

relaxed and calm

restlessness

runny nose

shuffling walk

sleepiness or unusual drowsiness

sleeplessness

slow movement or reflexes

slurred speech

sneezing

sore throat

stiffness of arms and legs

tic-like (jerky) movements of the head, face, mouth, and neck

tiredness

trembling and shaking of fingers and hands

trouble concentrating

trouble sleeping

trouble with balance

unable to sleep

unusual tiredness or weakness

Less common

Burning while urinating

changes in patterns and rhythms of speech

cough producing mucus

difficult or painful urination

dizziness

shortness of breath

tightness in chest

trouble in speaking

trouble in walking

wheezing

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

Symptoms of overdose

Blurred vision

diarrhea

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

fixed position of the eye

inability to move eyes

increased blinking or spasms of the eyelid

mood or mental changes

nausea and vomiting

seeing, hearing, or feeling things that are not there

shakiness in legs, arms, hands, or feet

sticking out of tongue

sweating

trembling or shaking of hands or feet

uncontrolled twisting movements of 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

Bruising

large, flat, blue, or purplish patches in the skin

Less common

Decreased appetite

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: tetrabenazine side effects (in more detail)

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More tetrabenazine resources

Tetrabenazine Side Effects (in more detail)
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Tetrabenazine Support Group
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Tetrabenazine Professional Patient Advice (Wolters Kluwer)

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