Frumeron may be available in the countries listed below.
Ingredient matches for Frumeron
Indapamide
Indapamide is reported as an ingredient of Frumeron in the following countries:
- Cyprus
International Drug Name Search
Tuesday, October 25, 2016
NiQuitin 7 mg transdermal patches
1. Name Of The Medicinal Product
NiQuitin 7 mg transdermal patches.
2. Qualitative And Quantitative Composition
Each 7 cm2 transdermal patch contains 36 mg nicotine, equivalent to 5.1 mg/cm2 of nicotine and delivering 7 mg over 24 hours.
For excipients, see section 6.1.
3. Pharmaceutical Form
Transdermal patch.
Each patch is rectangular and is comprised of an outer matt pinkish tan-coloured layer, a middle silver layer and an outer clear layer which is removed prior to use.
4. Clinical Particulars
4.1 Therapeutic Indications
NiQuitin patches relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence. They are indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.
NiQuitin patches are indicated in pregnant and lactating women making a quit attempt.
If possible, when stopping smoking, NiQuitin patches should be used in conjunction with a behavioural support programme.
4.2 Posology And Method Of Administration
NiQuitin patches should be applied once a day, at the same time each day and preferably soon after waking, to a non-hairy, clean, dry skin site and worn continuously for 24 hours. The NiQuitin patch should be applied promptly on removal from its protective sachet.
Avoid applying to any skin which is broken, red or irritated. After 24 hours the used patch should be removed and a new patch applied to a fresh skin site. The patch should not be left on for longer than 24 hours. Skin sites should not be reused for at least seven days. Only one patch should be worn at a time.
Patches may be removed before going to bed if desired. However use for 24 hours is recommended to optimise the effect against morning cravings.
Concurrent behavioural support is recommended, as such programmes have been shown to be beneficial for smoking cessation.
Adults 18 years and over
Abrupt cessation of smoking:
During a quit attempt every effort should be made to stop smoking with NiQuitin patches.
NiQuitin therapy should usually begin with NiQuitin 21 mg and be reduced according to the following dosing schedule:-
|
|
|
|
|
|
|
|
Light smokers (e.g. those who smoke less than 10 cigarettes per day) are recommended to start at Step 2 (14 mg) for 6 weeks and decrease the dose to NiQuitin 7 mg for the final 2 weeks.
Patients on NiQuitin 21 mg who experience excessive side-effects (please refer to precautions), which do not resolve within a few days, should change to NiQuitin 14mg. This strength should then be continued for the remainder of the 6 week course before stepping down to NiQuitin 7mg for two weeks. If the symptoms persist the patient should be advised to seek the advice of a healthcare professional.
For optimum results, the 10 week treatment course (8 weeks for light smokers or patients who have reduced strength as above), should be completed in full. Treatment with NiQuitin patch may be continued beyond 10 weeks if needed to stay cigarette free, however, those who have quit smoking but are having difficulty discontinuing using the patches recommended to seek additional help and advice from a healthcare professional.
Further courses may be used at a later time, for NiQuitin patch users who continue or resume smoking.
Gradual Cessation:
For smokers who are unwilling or unable to quit abruptly.
The 21 mg patch can be used daily for 2-4 weeks while the user continues to smoke as needed. At the end of the 2-4 weeks the user should quit completely and continue using Step 1 21 mg patch for 6 weeks daily without smoking. Thereafter following the Step 2 and 3 directions for abrupt cessation above. Should the patient feel able to quit completely before their designated quit date they can do so.
Reduction in smoking:
For smokers who wish to cut down with no immediate plans to quit.
A patch can be used while the user continues to smoke as needed. The user should reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. Users should be encouraged to stop smoking completely as soon as possible.
If users are still feeling the need to use the patches on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.
Temporary Abstinence
Apply a patch to control troublesome withdrawal symptoms including craving during the period when smoking is being avoided. Users should be encouraged to stop smoking completely as soon as possible.
If users are still feeling the need to use the patches on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.
Adolescents and children
Adolescents (12 to 17 years) should follow the schedule of treatment for abrupt cessation of smoking as given above. Where adolescents are not ready or not able to stop smoking abruptly, advice from a healthcare professional should be sought.
Safety and effectiveness in children who smoke has not been evaluated. NiQuitin is not recommended for use in children under 12 years of age.
4.3 Contraindications
NiQuitin is contraindicated in patients with hypersensitivity to the system, the active substance, or any of the excipients.
NiQuitin patches should not be used by non-smokers, occasional smokers or children under 12 years.
4.4 Special Warnings And Precautions For Use
The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well established dangers of continued smoking.
Patients hospitalised for MI, severe dysrhythmia or CVA who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, NiQuitin patches may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital they can use NRT as normal.
Diabetes Mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.
Allergic reactions: Susceptibility to angioedema and urticaria.
Atopic or eczematous dermatitis (due to localised patch sensitivity): In the case of severe or persistent local reactions at the site of application (e.g. severe erythema, pruritus or oedema) or a generalised skin reaction (e.g. urticaria, hives or generalised skin rashes), users should be instructed to discontinue use of NiQuitin and contact their physician.
Contact sensitisation: Patients with contact sensitisation should be cautioned that a serious reaction could occur from exposure to other nicotine-containing products or smoking.
A risk benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:
• Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.
• Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.
Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. The patches should be folded in half with the adhesive side innermost and disposed of with care.
Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.
Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.
Safety on handling: NiQuitin is potentially a dermal irritant and can cause contact sensitisation. Care should be taken during handling and in particular contact with the eyes and nose avoided. After handling, wash hands with water alone as soap may increase nicotine absorption.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.
4.6 Pregnancy And Lactation
Pregnancy
Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but NRT may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine.
Lactation
The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
NRT may cause adverse reactions similar to those associated with nicotine administered by other means, including smoking. These may be attributable to the pharmacological effects of nicotine, some of which are dose dependent. At recommended doses, NiQuitin patches have not been found to cause any serious adverse effects. Excessive use of NiQuitin patches by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.
Subjects quitting smoking by any means could expect to suffer from asthenia, headache, dizziness, sleep disturbance, coughing or influenza-like illness. Certain symptoms which have been reported such as depression, irritability, nervousness, restlessness, mood lability, anxiety, drowsiness, impaired concentration and insomnia may be related to withdrawal symptoms associated with smoking cessation.
Application site reactions are the most frequent adverse reaction associated with NiQuitin. NiQuitin can cause other adverse reactions related to the pharmacological effect of nicotine or withdrawal effects related to smoking.
The following undesirable effects have been reported in clinical trials or spontaneously post-marketing.
Certain symptoms which have been reported such as depression, irritability, nervousness, restlessness, mood lability, anxiety, drowsiness, impaired concentration, insomnia and sleep disturbances may be related to withdrawal symptoms associated with smoking cessation. Subjects quitting smoking by any means could expect to suffer from asthenia, headache, dizziness, coughing or influenza-like illness.
Immune System Disorders
Uncommon>1/1000; <1/100: hypersensitivity NOS*
Very rare <1/10000: anaphylactic reactions
Psychiatric
Very common>1/10: sleep disorders including abnormal dreams and insomnia
Common>1/100; <1/10: nervousness
Nervous system disorders
Very Common>1/10: headache, dizziness
Common>1/100; <1/10: tremor
Cardiac disorders
Common>1/100; <1/10: palpitations
Uncommon>1/1000; <1/100: tachycardia NOS
Respiratory, Thoracic and Mediastinal Disorders
Common>1/100; <1/10: dyspnoea, pharyngitis, cough
Gastrointestinal Disorders
Very Common>1/10: nausea, vomiting
Common>1/100; <1/10: dyspepsia, abdominal pain upper, diarrhea NOS, dry mouth, constipation
Skin and Subcutaneous Tissue Disorders
Common>1/100; <1/10: sweating increased
Very rare> 1/100000; <1/10000: dermatitis allergic*, dermatitis contact*, photosensitivity
Musculoskeletal and Connective Tissue Disorders
Common>1/100; <1/10: arthralgia, myalgia
General Disorders and Administration Site Conditions
Very Common>1/10: application site reactions NOS*
Common>1/100; <1/10: chest pain, pain in limb, pain NOS, asthenia, fatigue
Uncommon>1/1000; <1/100 malaise, influenza-like illness
* see below
Application site reactions, including transient rash, itching, burning, tingling, numbness, swelling, pain and urticaria are the most frequent undesirable effects of NiQuitin patch. The majority of these topical reactions are minor and resolve quickly following removal of the patch. Pain or sensation of heaviness in the limb or area around which the patch is applied (e.g. chest) may be reported.
Hypersensitivity reactions, including contact dermatitis and allergic dermatitis have also been reported. In the case of severe or persistent local reactions at the application site (e.g. severe erythema, pruritus or oedema) or a generalized skin reaction (e.g. urticaria, hives or generalised skin rashes) users should be instructed to discontinue use of NiQuitin and contact their physician.
If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the NiQuitin dose should be reduced or discontinued.
4.9 Overdose
Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.
Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine
Overdose from topical exposure: The NiQuitin system should be removed immediately if the patient shows signs of overdosage and the patient should seek immediate medical care. The skin surface may be flushed with water and dried. No soap should be used since it may increase nicotine absorption. Nicotine will continue to be delivered into the bloodstream for several hours after removal of the system because of a depot of nicotine in the skin.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic classification: N07BA01
(Anti-smoking agents: N07BA, Nicotine 01)
Nicotine, the chief alkaloid in tobacco products and a naturally occurring autonomic drug, is an agonist at nicotine receptors in the peripheral and central nervous system and has pronounced CNS and cardiovascular effects. Withdrawal from nicotine in addicted individuals is characterised by craving, nervousness, restlessness, irritability, mood lability, anxiety, drowsiness, sleep disturbances, impaired concentration, increased appetite, minor somatic complaints (headache, myalgia, constipation, fatigue) and weight gain. Withdrawal symptoms, such as cigarette craving, may be controlled in some individuals by steady-state plasma levels lower than those for smoking.
In clinically controlled trials, NiQuitin was shown to alleviate nicotine withdrawal symptoms as well as craving. NiQuitin reduced the severity of cravings by at least 35% at all times of day during the first two weeks of abstinence, compared to placebo (p<0.05).
5.2 Pharmacokinetic Properties
Absorption
Following transdermal application, the skin rapidly absorbs nicotine released initially from the patch adhesive. The plasma concentrations of nicotine reach a plateau within 2-4 hours after initial application of NiQuitin with relatively constant plasma concentrations persisting for 24 hours or until the patch is removed. Approximately 68% of the nicotine released from the patch enters systemic circulation and the remainder of the released nicotine is lost via vaporisation from the edge of the patch.
With continuous daily application of NiQuitin (worn for 24 hours), dose-dependent steady state plasma nicotine concentrations are achieved following the second NiQuitin application and are maintained throughout the day. These steady state maximum concentrations are approximately 30% higher than those following a single application of NiQuitin.
Plasma concentrations of nicotine are proportional to dose for the three dosage forms of NiQuitin. The mean plasma steady state concentrations of nicotine are approximately 17 ng/ml for the 21 mg/day patch, 12 ng/ml for the 14 mg /day patch and 6 ng/ml for the 7 mg/day patch. For comparison, half-hourly smoking of cigarettes produces average plasma concentrations of approximately 44 ng/ml.
The pronounced early peak in nicotine blood levels seen with inhalation of cigarette smoke is not observed with NiQuitin.
Distribution
Following removal of NiQuitin, plasma nicotine concentrations decline with an apparent mean half-life of 3 hours, compared with 2 hours for IV administration due to continued absorption of nicotine from the skin depot. If NiQuitin is removed most non-smoking patients will have non-detectable nicotine concentrations in 10 to 12 hours.
A dose of radiolabelled nicotine given intravenously showed a distribution of radioactivity corresponding to the blood supply with no organ selectively taking up nicotine. The volume of distribution of nicotine is approximately 2.5 l/kg.
Metabolism
The major elimination organ is the liver and average plasma clearance is about 1.2 l/min; the kidney and the lung also metabolise nicotine. More than 20 metabolites of nicotine have been identified, all of which are believed to be pharmacologically inactive. The principal metabolites are cotinine and trans
Excretion
Both nicotine and its metabolites are excreted through the kidneys and about 10% of nicotine is excreted unchanged in the urine. As much as 30% may be excreted in the urine with maximum flow rates and extreme urine acidification (pH
There were no differences in nicotine kinetics between men and women using NiQuitin. Obese men using NiQuitin had significantly lower AUC and Cmax values compared with normal weight men. Linear regression of AUC vs total body weight showed the expected inverse relationship (AUC decreases as weight increases). Nicotine kinetics were similar for all sites of application on the upper body and upper outer arm.
5.3 Preclinical Safety Data
The general toxicity of nicotine is well known and taken into account in the recommended posology. Nicotine was not mutagenic in appropriate assays. The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine. In studies in pregnant animals, nicotine showed maternal toxicity, and consequential mild fetal toxicity. Additional effects included pre- and postnatal growth retardation and delays and changes in postnatal CNS development.
Effects were only noted following exposure to nicotine at levels in excess of those which will result from recommended use of NiQuitin. Effects on fertility have not been established.
Comparison of the systemic exposure necessary to elicit these adverse responses from preclinical test systems with that associated with the recommended use of NiQuitin indicate that the potential risk is low and outweighed by the demonstrable benefit of nicotine therapy in smoking cessation. However, NiQuitin should only be used by pregnant women on medical advice if other forms of treatment have failed.
6. Pharmaceutical Particulars
6.1 List Of Excipients
|
|
|
|
|
|
|
|
|
|
|
|
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
7 or 14 patches in a carton. Each patch is contained in a laminate sachet.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Beecham Group PLC
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
T/A GlaxoSmithKline Consumer Healthcare
Brentford
TW8 9GS
8. Marketing Authorisation Number(S)
PL 00079/0366
9. Date Of First Authorisation/Renewal Of The Authorisation
22/04/2009
10. Date Of Revision Of The Text
11/10/2010
Monday, October 24, 2016
Neostigmina Bromuro L.CH.
Neostigmina Bromuro L.CH. may be available in the countries listed below.
Ingredient matches for Neostigmina Bromuro L.CH.
Neostigmine
Neostigmine bromide (a derivative of Neostigmine) is reported as an ingredient of Neostigmina Bromuro L.CH. in the following countries:
- Chile
International Drug Name Search
Bambermycin
In some countries, this medicine may only be approved for veterinary use.
Scheme
Prop.INN
CAS registry number (Chemical Abstracts Service)
0011015-37-5
Therapeutic Category
Antibacterial
Chemical Name
Antibiotic complex, containing mainly moenomycin A and C, obtained from cultures of Streptomyces bambergiensis
Foreign Names
- Bambermycinum (Latin)
- Bambermycin (German)
- Bambermycine (French)
- Bambermicina (Spanish)
Generic Names
- Bambermycin (OS: BAN)
- Bambermycins (OS: USAN)
- Flavophospholipol (IS)
- Moenomycin (IS)
Brand Names
- Amprolium (Bambermycin and Amprolium (veterinary use))
Huvepharma, United States - Avatec (Bambermycin and Lasalocid (veterinary use))
Huvepharma, United States - Bambermycin (veterinary use)
Ceva Animal Health, South Africa - Bio Cox (Bambermycin and Salinomycin (veterinary use))
Alpharma Animal Health, United States - Carb O Sep (Bambermycin and Carbarsone (veterinary use))
Huvepharma, United States - Clinacox (Bambermycin and Diclazuril (veterinary use))
Huvepharma, United States - Flaveco (veterinary use)
Afrivet, South Africa; Eco Animal Health, United Kingdom; International Animal Health, Australia - Flavomycin (Bambermycin and Amprolium (veterinary use))
Huvepharma, United States - Flavomycin (Bambermycin and Carbarsone (veterinary use))
Huvepharma, United States - Flavomycin (Bambermycin and Diclazuril (veterinary use))
Huvepharma, United States - Flavomycin (Bambermycin and Dinitolmide (veterinary use))
Huvepharma, United States - Flavomycin (Bambermycin and Halofuginone (veterinary use))
Huvepharma, United States - Flavomycin (Bambermycin and Lasalocid (veterinary use))
Huvepharma, United States - Flavomycin (Bambermycin and Monensin (veterinary use))
Huvepharma, United States - Flavomycin (Bambermycin and Narasin (veterinary use))
Huvepharma, United States - Flavomycin (Bambermycin and Nicarbazin (veterinary use))
Huvepharma, United States - Flavomycin (Bambermycin and Salinomycin (veterinary use))
Alpharma Animal Health, United States; Huvepharma, United States - Flavomycin (veterinary use)
ADM Alliance Nutrition, United States; Combipharm, South Africa; Huvepharma, United States; Intervet, United Kingdom; North American, United States; Quali Tech, United States - Gainpro (veterinary use)
Huvepharma, United States - MDB Flavo 4 (veterinary use)
Ceva Animal Health, South Africa - Monensin (Bambermycin and Monensin (veterinary use))
Huvepharma, United States - Monteban (Bambermycin and Narasin (veterinary use))
Huvepharma, United States - Nicarb (Bambermycin and Nicarbazin (veterinary use))
Huvepharma, United States - Pharmastim (veterinary use)
Combipharm, South Africa - Sacox (Bambermycin and Salinomycin (veterinary use))
Huvepharma, United States - Stenorol (Bambermycin and Halofuginone (veterinary use))
Huvepharma, United States - Zoalene (Bambermycin and Dinitolmide (veterinary use))
Huvepharma, United States
International Drug Name Search
Glossary
| BAN | British Approved Name |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Prop.INN | Proposed International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Friday, October 21, 2016
Nesivine Enfant
Nesivine Enfant may be available in the countries listed below.
Ingredient matches for Nesivine Enfant
Oxymetazoline
Oxymetazoline hydrochloride (a derivative of Oxymetazoline) is reported as an ingredient of Nesivine Enfant in the following countries:
- Belgium
International Drug Name Search
Ampicillin
Class: Aminopenicillins
Note: This monograph also contains information on Ampicillin Trihydrate, Ampicillin Sodium, Ampicillin Trihydrate
Chemical Name: [2S - [2α,5α,6β(S*)]] - 6 - [(Aminophenylacetyl)amino] - 3,3 - dimethyl - 7 - oxo - 4 - thia - 1 - azabicyclo[3.2.0]heptane - 2 - carboxylic acid
Molecular Formula: C16H19N3O4SC16H19N3O4S•NaC16H19N3O4S•3H2O
CAS Number: 69-53-4
Brands: Principen
Introduction
Antibacterial; β-lactam antibiotic; aminopenicillin.1 2 8 9
Uses for Ampicillin
Endocarditis
Treatment of enterococcal endocarditis;2 4 6 7 used in conjunction with an aminoglycoside.4 6 7
Treatment of endocarditis caused by slow-growing fastidious gram-negative bacilli termed the HACEK group† (i.e., Haemophilus parainfluenzae, H. aphrophilus, Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, Kingella kingae).6 7 Used in conjunction with gentamicin; consider that these infections may involve β-lacatamase-producing bacteria resistant to ampicillin alone.6 7
Treatment of endocarditis caused by susceptible staphylococci, streptococci, E. coli, P. mirabilis, or Salmonella.2
Prevention of bacterial endocarditis in patients undergoing certain dental, oral, respiratory tract, or esophageal procedures† who have cardiac conditions that put them at moderate or high risk.10 AHA recommends ampicillin as a drug of choice.10
Prevention of bacterial endocarditis in patients undergoing certain GU and GI (except esophageal) procedures† who have cardiac conditions that put them at moderate or high risk.10 AHA recommends ampicillin as a drug of choice.10 Used alone in those at moderate risk or in conjunction with gentamicin in those at high risk.10
Consult most recent AHA recommendations for specific information on which cardiac conditions are associated with high or moderate risk of endocarditis and which procedures require prophylaxis.10
Meningitis and Other CNS Infections
Treatment of meningitis caused by susceptible Neisseria meningitidis,2 5 Streptococcus agalactiae (group B streptococci),2 5 Listeria monocytogenes,2 4 5 E. coli,2 5 H. influenzae†,5 or S. pneumoniae†.
Drug of choice for empiric treatment of neonatal S. agalactiae meningitis.5 An aminoglycoside (IV gentamicin) used concomitantly until in vitro susceptibility testing is complete and a clinical response obtained;5 treatment can then be changed to penicillin G.5
Drug of choice for L. monocytogenes meningitis;4 5 9 used alone or in conjunction with an aminoglycoside (e.g., gentamicin).4 5 9
Penicillin G usually preferred for N. meningitidis meningitis and penicillin-susceptible S. pneumoniae meningitis.5 For H. influenzae meningitis, cefotaxime, ceftriaxone, or, alternatively, ampicillin in conjunction with chloramphenicol is recommended; ampicillin should not be used alone (see Ampicillin-resistant Haemophilus influenzae under Cautions).5
Respiratory Tract Infections
Treatment of respiratory tract infections caused by susceptible Staphylococcus aureus (including penicillinase-producing strains), Streptococcus (including S. pneumoniae), S. pyogenes (group A β-hemolytic streptococci), or H. influenzae (nonpenicillinase-producing strains only).1 2 9
Generally should not be used for the treatment of streptococcal or staphylococcal infections when a natural penicillin would be effective.4 5 8 9 Should not be used alone for empiric treatment of respiratory tract infections when ampicillin-resistant H. influenzae may be involved.5 9
Septicemia
Treatment of septicemia caused by susceptible staphylococci, streptococci, enterococci, E. coli, P. mirabilis, or Salmonella.2 9
Urinary Tract Infections (UTIs)
Treatment of UTIs caused by susceptible enterococci, E. coli, or Proteus mirabilis.1 2 9
A drug of choice for enterococcal UTIs.4 9 Because of high urinary concentrations, may be effective when used alone,9 but consider that enterococci resistant to ampicillin have been reported.4
Eikenella Infections
Treatment of infections caused by Eikenella corrodens†; drug of choice.4
Gonorrhea and Associated Infections
Previously used for treatment of acute uncomplicated gonorrhea (anogenital and urethral) caused by susceptible Neisseria gonorrhoeae.1 Has been used for gonococcal urethritis.2 No longer recommended for gonorrhea or gonococcal urethritis by CDC or other experts (high incidence of penicillin-resistant strains).11
Listeria Infections
Treatment of infections caused by Listeria monocytogenes; used alone or in conjunction with an aminoglycoside.5 9
A drug of choice for Listeria infections occurring during pregnancy, granulomatosis infantiseptica, sepsis, endocarditis, meningitis, and foodborne infections.4 5 9 9 (See Meningitis and Other CNS Infections under Uses.)
Pertussis
Has been used to treat and prevent secondary pulmonary infections in patients with pertussis†.9 Erythromycin generally considered drug of choice for treatment of catarrhal stage of pertussis and to shorten the period of communicability of the disease.5 9 Ampicillin, like most other anti-infectives, does not shorten clinical course of pertussis.9
Typhoid Fever and Other Salmonella Infections
Alternative for treatment of typhoid fever (enteric fever) caused by susceptible Salmonella typhi.2 4 5 9 Drugs of choice are third generation cephalosporins (e.g., ceftriaxone, cefotaxime) or fluoroquinolones (e.g., ciprofloxacin, ofloxacin);4 consider that multidrug-resistant strains of S. typhi (strains resistant to ampicillin, amoxicillin, chloramphenicol, and/or co-trimoxazole) reported with increasing frequency.5
Treatment of chronic carriers of S. typhi†; drugs of choice are fluoroquinolones (e.g., ciprofloxacin), ampicillin, or amoxicillin (with probenecid).5 8 9
Treatment of gastroenteritis caused by susceptible Salmonella.2 4 5
Long-term suppressive or maintenance therapy (secondary prophylaxis) in HIV-infected patients to prevent recurrence of nontyphi Salmonella septicemia†.
Shigella Infections
Treatment of GI infections caused by susceptible Shigella.1 2 5 9
Anti-infectives generally indicated in addition to fluid and electrolyte replacement for severe shigellosis.5 9 Previously considered a drug of choice for shigellosis (especially in children),9 but strains of S. flexneri and S. sonnei resistant to ampicillin reported with increasing frequency.9 Fluoroquinolones, ceftriaxone, or co-trimoxazole now considered drugs of choice for empiric treatment,4 5 9 especially in areas where ampicillin-resistant strains of Shigella have been reported.5 9
Prevention of Perinatal Group B Streptococcal Disease
Prevention of early-onset neonatal group B streptococcal (GBS) disease†.5
Intrapartum anti-infective prophylaxis to prevent early-onset neonatal GBS disease is administered to women identified as GBS carriers during routine prenatal GBS screening performed at 35–37 weeks during the current pregnancy and to women who have GBS bacteriuria during the current pregnancy, a previous infant with invasive GBS disease, unknown GBS status with delivery at <37 weeks gestation, amniotic membrane rupture for ≥18 hours, or intrapartum temperature of ≥38°C.
When intrapartum GBS prophylaxis is indicated, IV penicillin G is the drug of choice. Although IV ampicillin can be used, CDC and AAP state that penicillin G is preferred since it has a narrower spectrum of activity and is less likely to select for antibiotic-resistant organisms.
Perioperative Prophylaxis
Has been used for perioperative prophylaxis† in patients undergoing vaginal hysterectomy or cesarean section. Cephalosporins (cefazolin, cefotetan, cefoxitin) usually drugs of choice for perioperative prophylaxis in patients undergoing obstetric and gynecologic surgery.
Perioperative prophylaxis in patients undergoing biliary tract or intestinal surgery including appendectomy†. Cephalosporins (cefazolin, cefoxitin) usually drugs of choice.
Ampicillin Dosage and Administration
Administration
Administer orally,1 by slow IV injection or infusion,2 or by IM injection.2
Parenteral route used for treatment of moderately severe or severe infections.2 Oral route should not be used for initial treatment of severe, life-threatening infections, but may be used as follow-up after parenteral ampicillin.
Oral Administration
Administer orally with a full glass of water 1 hour before or 2 hours after meals.1
IV Administration
Reconstitution
Reconstitute vials containing 125, 250, or 500 mg with 5 mL of sterile or bacteriostatic water for injection.2 Alternatively, reconstitute vials containing 1 or 2 g with 7.4 or 14.8 mL, respectively, of sterile or bacteriostatic water for injection.2
Rate of Administration
Solutions reconstituted from 125-, 250-, or 500-mg vials may be given by IV injection over a period of 3–5 minutes.2 Solutions reconstituted from 1- or 2-g vials should be given IV over a period of ≥10–15 minutes.2
For IV infusion, concentration and rate of administration should be adjusted so that the total dose is administered before the drug is inactivated in the IV solution.2
IM Administration
Reconstitution
Reconstitute with sterile or bacteriostatic water for injection according to manufacturer's directions to provide solutions containing 125 or 250 mg/mL.2
Dosage
Available as ampicillin trihydrate1 and ampicillin sodium2 ; dosage expressed in terms of ampicillin.1 2
Duration of therapy depends on type and severity of infection and should be determined by clinical and bacteriologic response of the patient.1 2 For most infections, therapy should be continued for ≥48–72 hours after patient becomes asymptomatic or evidence of eradication of the infection has been obtained.1 2 More prolonged therapy may be necessary for some infections.1 2
Pediatric Patients
General Pediatric Dosage
Oral
Children ≥1 month of age: AAP recommends 50–100 mg/kg daily given in 4 divided doses for mild to moderate infections.5
AAP states oral route is inappropriate for severe infections.5
IV or IM
Neonates <1 week of age: AAP recommends 25–50 mg/kg every 12 hours in those weighing ≤2 kg or 25–50 mg/kg every 8 hours in those weighing >2 kg.5
Neonates 1–4 weeks of age: AAP recommends 25–50 mg/kg every 12 hours for those weighing <1.2 kg, 25–50 mg/kg every 8 hours for those weighing 1.2–2 kg, or 25–50 mg/kg every 6 hours for those weighing >2 kg.5
Children ≥1 month of age: AAP recommends 100–150 mg/kg daily given in 4 divided doses for mild to moderate infections or 200–400 mg/kg daily given in 4 divided doses for severe infections.5
Endocarditis
Treatment of Endocarditis Caused by Viridans Streptococci or S. bovis
IV
300 mg/kg daily given in 4–6 divided doses for 4 weeks.7 Used in conjunction with IM or IV gentamicin (3 mg daily given during the first 2 weeks).7
Treatment of Enterococcal Endocarditis
IV
300 mg/kg daily given in 4–6 divided doses for 4–6 weeks.7 Used in conjunction with IM or IV gentamicin (3 mg daily given for 4–6 weeks).7
Prevention of Bacterial Endocarditis in Patients Undergoing Certain Dental, Oral, Respiratory Tract, or Esophageal Procedures†
IV or IM
50 mg/kg given 30 minutes prior to the procedure.10
Prevention of Enterococcal Endocarditis in Patients Undergoing Certain Genitourinary or GI (except Esophageal) Procedures†
IV or IM
For moderate-risk patients, 50 mg/kg given 30 minutes prior to the procedure.10
For high-risk patients, 50 mg/kg (up to 2 g) as a single dose in conjunction with a single dose of gentamicin (1.5 mg/kg) given 30 minutes prior to the procedure followed a dose of IM or IV ampicillin (25 mg/kg) given 6 hours later or, alternatively, oral amoxicillin (25 mg/kg) given 6 hours later.10
GI Infections
Oral
Children weighing ≤20 kg: 100 mg/kg daily in 4 divided doses.1
Children weighing >20 kg: 500 mg 4 times daily.1 Severe or chronic infections may require higher dosage.1
IV or IM
Children weighing <40 kg: 50 mg/kg daily in divided doses every 6–8 hours.2
Children weighing ≥40 kg: 500 mg every 6 hours.2 Severe or chronic infections may require higher dosage.1
Meningitis and Other CNS Infections
Empiric Treatment of Meningitis
IV
Neonates and children <2 months of age: 100–300 mg/kg daily given in divided doses; used in conjunction with IM gentamicin pending results of in vitro susceptibility tests.
Children 2 months to 12 years of age: 200–400 mg/kg daily given in divided doses every 4–6 hours; used in conjunction with IV chloramphenicol.
Treatment of Meningitis Caused by S. agalactiae
IV
AAP recommends 200–300 mg/kg daily given in 3 divided for neonates ≤7 days of age or 300 mg/kg daily given in 4–6 divided doses for neonates >7 days of age.5
Respiratory Tract Infections
Oral
Children weighing ≤20 kg: 50 mg/kg daily in 3 or 4 divided doses.1
Children weighing >20 kg: 250 mg 4 times daily.1
IV or IM
Children weighing <40 kg: 25–50 mg/kg daily in divided doses every 6–8 hours.2
Children weighing ≥40 kg: 250–500 mg every 6 hours.2
Septicemia
IV or IM
150–200 mg/kg daily.2
Skin and Skin Structure Infections
IV or IM
Children weighing <40 kg: 25–50 mg/kg daily in divided doses every 6–8 hours.2
Children weighing ≥40 kg: 250–500 mg every 6 hours.2
Urinary Tract Infections (UTIs)
Oral
Children weighing ≤20 kg: 100 mg/kg daily in 4 divided doses.1
Children weighing >20 kg: 500 mg 4 times daily.1 Severe or chronic infections may require higher dosage.1
IV or IM
Children weighing <40 kg: 50 mg/kg daily in divided doses every 6–8 hours.2
Children weighing ≥40 kg: 500 mg every 6 hours.2 Severe or chronic infections may require higher dosage.1
Adults
Endocarditis
Treatment of Enterococcal Endocarditis
IV
12 g daily (by continuous IV infusion or in 6 equally divided IV doses) in conjunction with IM or IV gentamicin (1 mg/kg every 8 hours).6 Treatment with both drugs generally should be continued for 4–6 weeks, but patients who had symptoms of infection for >3 months before treatment was initiated and patients with prosthetic heart valves require ≥6 weeks of therapy with both drugs.6
Treatment of Endocarditis Caused by HACEK group (i.e., H. parainfluenzae, H. aphrophilus, A. actinomycetemcomitans, C. hominis, E. corrodens, K. kingae)†
IV
12 g daily (by continuous IV infusion or in 6 equally divided IV doses) in conjunction with IM or IV gentamicin (1 mg/kg every 8 hours).6 Treatment with both drugs generally should be continued for 4 weeks.6
Prevention of Bacterial Endocarditis in Patients Undergoing Certain Dental, Oral, Respiratory Tract, or Esophageal Procedures†
IV or IM
2 g as a single dose given 30 minutes prior to the procedure.10
Prevention of Enterococcal Endocarditis in Patients Undergoing Certain GU or GI (except Esophageal) Procedures†
IV or IM
For moderate-risk patients, 2 g given 30 minutes prior to the procedure.10
For high-risk patients, 2 g as a single dose in conjunction with a single dose of gentamicin (1.5 mg/kg) given 30 minutes prior to the procedure followed by a dose of IM or IV ampicillin (1 g) given 6 hours later or, alternatively, a dose of oral amoxicillin (1 g) given 6 hours later.10
GI Infections
Oral
500 mg 4 times daily.1
IV or IM
Adults weighing <40 kg: 50 mg/kg daily in divided doses every 6–8 hours.2
Adults weighing ≥40 kg: 500 mg every 6 hours.2
Meningitis and Other CNS Infections
IV, then IM
150–200 mg/kg daily in divided doses every 3–4 hours.2 Use IV initially, may switch to IM after 3 days.2
Respiratory Tract Infections
Oral
250 mg 4 times daily.1
IV or IM
Adults weighing <40 kg: 25–50 mg/kg daily in divided doses every 6–8 hours.2
Adults weighing ≥40 kg: 250–500 mg every 6 hours.2
Septicemia
IV or IM
150–200 mg/kg daily.2
Skin and Skin Structure Infections
IV or IM
Adults weighing <40 kg: 25–50 mg/kg daily in divided doses every 6–8 hours.2
Adults weighing ≥40 kg: 250–500 mg every 6 hours.2
Urinary Tract Infections (UTIs)
Oral
500 mg 4 times daily.1
IV or IM
Adults weighing <40 kg: 50 mg/kg daily in divided doses every 6–8 hours.2
Adults weighing ≥40 kg: 500 mg every 6 hours.2
Gonorrhea and Associated Infections
Uncomplicated Gonorrhea
Oral
3.5 g as a single dose (with 1 g of oral probenecid).1 No longer recommended for gonorrhea by CDC or other experts.11
Gonococcal Urethritis
IV or IM
500 mg initially followed by 500 mg 8–12 hours later.2 No longer recommended by CDC or other experts.11
Prevention of Perinatal Group B Streptococcal (GBS) Disease†
IV
An initial 2-g dose (at time of labor or rupture of membranes) followed by 1 g every 4 hours until delivery.
Prescribing Limits
Pediatric Patients
Pediatric dosage should not exceed adult dosage.1
Special Populations
Renal Impairment
Dosage adjustments necessary in patients with renal impairment.9
Some clinicians suggest that adults with GFR 10–50 mL/minute receive the usual dose every 6–12 hours and that adults with GFR <10 mL/minute receive the usual dose every 12–16 hours. Alternatively, some clinicians suggest that modification of usual dosage is unnecessary in adults with Clcr ≥ 30 mL/minute, but that adults with Clcr ≤10 mL/minute should receive the usual dose every 8 hours.
Patients undergoing hemodialysis should receive a supplemental dose after each dialysis period.
Geriatric Patients
No dosage adjustments except those related to renal impairment. (See Renal Impairment under Dosage and Administration.)
Cautions for Ampicillin
Contraindications
Known hypersensitivity to any penicillin.1 2
Warnings/Precautions
Warnings
Superinfection/Clostridium difficile-associated Colitis
Possible emergence and overgrowth of nonsusceptible bacteria or fungi.1 2 Discontinue and institute appropriate therapy if superinfection occurs.1 2
Treatment with anti-infectives may permit overgrowth of clostridia.1 Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.1
Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone.1 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.1
Sensitivity Reactions
Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, reported with penicillins.1 2 9
Prior to initiation of therapy, make careful inquiry regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other drugs.1 2 Partial cross-allergenicity occurs among penicillins and other β-lactam antibiotics including cephalosporins and cephamycins.1 2
If a severe hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).1 2
General Precautions
Selection and Use of Anti-infectives
To reduce development of drug-resistant bacteria and maintain effectiveness of ampicillin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.
When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 2 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1 2
Mononucleosis
Possible increased risk of rash in patients with mononucleosis; use in these patients not recommended.
Ampicillin-resistant Haemophilus influenzae
Because of increasing prevalence of ampicillin-resistant H. influenzae,5 the drug should not be used alone for empiric treatment of serious infections (e.g., meningitis, pneumonia) when H. influenzae may be involved.5 9
Laboratory Monitoring
Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during prolonged therapy.1 2
Sodium Content
Powder for injection contains 2.9 mEq of sodium per g of ampicillin.2
Specific Populations
Pregnancy
Category B.1 2
Lactation
Distributed into milk.1 2 9 Use with caution.1 2
Pediatric Use
Renal clearance of ampicillin may be delayed in neonates and young infants because of incompletely developed renal function.1 9 Use lowest effective dosage.1
Renal Impairment
Dosage adjustments necessary in renal impairment.9 (See Renal Impairment under Dosage and Administration.)
Common Adverse Effects
GI effects (diarrhea, nausea), rash.
Interactions for Ampicillin
Specific Drugs and Laboratory Tests
Drug or Test | Interaction | Comments |
|---|---|---|
Allopurinol | Possible increased incidence of rash | Unclear whether potentiation of rash is caused by allopurinol or hyperuricemia present in these patients Clinical importance has not been determined; some clinicians suggest that concomitant use of the drugs should be avoided if possible |
Aminoglycosides | In vitro evidence of synergistic antibacterial effects against enterococci; used to therapeutic advantage in treatment of endocarditis and other severe enterococcal infections Potential in vitro and in vivo inactivation of aminoglycosidesHID | |
Chloramphenicol | In vitro evidence of antagonism | Clinical importance unclear |
Hormonal contraceptives | Possible decreased efficacy of estrogen-containing oral contraceptives and increased incidence of breakthrough bleeding | Some clinicians suggest that a supplemental method of contraception be used in patients receiving oral contraceptives and ampicillin concomitantly, other clinicians state that most women taking oral contraceptives probably do not need to use alternative contraceptive precautions while receiving ampicillin |
Methotrexate | Possible decreased renal clearance of methotrexate with penicillins; possible increased methotrexate concentrations and hematologic and GI toxicity | Monitor closely if used concomitantly |
Probenecid | Decreased renal tubular secretion of ampicillin; increased and prolonged ampicillin concentrations may occur9 | |
Sulbactam | Synergistic bactericidal effect against many strains of β-lactamase-producing bacteria | |
Sulfonamides | In vitro evidence of antagonism1 | Clinical importance unclear1 |
Tests for glucose | Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution1 2 | Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)1 2 |
Tests for uric acid | Possible falsely increased serum uric acid concentrations when copper-chelate method is used; phosphotungstate and uricase methods appear to be unaffected by the ampicillin |
Ampicillin Pharmacokinetics
Absorption
Bioavailability
30–55% of an oral dose absorbed from the GI tract in fasting adults; peak serum concentrations attained within 1–2 hours.9
Following IM administration, peak serum concentrations generally attained more quickly and are higher than following equivalent oral doses.9
Rapid IV administration results in peak serum concentrations immediately after completion of the infusion; serum concentrations may still be detectable 6 hours later.
Food
Food generally decreases rate and extent of absorption.9
Distribution
Extent
Distributed into ascitic, synovial, and pleural fluids. Also distributed into liver, bile,9 lungs, gallbladder, prostate, muscle, middle ear effusions, bronchial secretions, sputum, maxillary sinus secretions, tonsils, saliva, sweat, and tears.
Distributed into CSF in concentrations 11–65% of simultaneous serum concentrations; highest CSF concentrations occur 3–7 hours after an IV dose.
Readily crosses the placenta.9 Distributed into milk in low concentrations.
Plasma Protein Binding
15–25%.1 2 9
Protein binding is lower in neonates than in children or adults; ampicillin reportedly 8–12% bound to serum proteins in neonates.
Elimination
Metabolism
Partially metabolized by hydrolysis of the β-lactam ring to penicilloic acid which is microbiologically inactive.9
Elimination Route
Eliminated in urine by renal tubular secretion and to a lesser extent by glomerular filtration.9 Small amounts also excreted in feces and bile.9
In adults with normal renal function, approximately 20–64% of a single oral dose9 excreted unchanged in urine within 6–8 hours. Approximately 60–70% of a single IM dose or 73–90% of a single IV dose excreted unchanged in urine.
Half-life
0.7–1.5 hours in adults with normal renal function.9
Half-life is 4 hours in neonates 2–7 days of age, 2.8 hours in neonates 8–14 days of age, and 1.7 hours in neonates 15–30 days of age.9
Special Populations
Serum concentrations higher and more prolonged in premature or full-term neonates <6 days of age than in full-term neonates ≥6 days of age.
Renal clearance decreased in geriatric patients because of diminished tubular secretory ability; serum concentrations may be higher and half-life prolonged. In those 67–76 years of age, half-life ranges from 1.4–6.2 hours.
Serum concentrations are higher and half-life prolonged in patients with impaired renal function. Half-life may range from 7.4–21 hours in patients with Clcr <10 mL/minute9
Stability
Storage
Oral
Capsules
Tight container at 15–30°C; avoid excessive heat.1
For Suspension
Tight container at 15–30°C.1 After reconstitution, discard after 7 days if stored at room temperature or after 14 days if refrigerated.1
Parenteral
Powder for Injection or Infusion
Solutions for IM injection or IV injection or infusion should be used within 1 hour after reconstitution and should not be frozen.2
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Parenteral
Solution CompatibilityHID
Compatible |
|---|
Isolyte M or P with dextrose 5% |
Incompatible |
Amino acids 4.25%, dextrose 25% |
Dextran 40 10% in sodium chloride 0.9% |
Dextran 40 10% in dextrose 5% in water |
Dextran 70 6% in sodium chloride 0.9% |
Dextran 70 6% in dextrose 5% in water |
Dextrose 5% in sodium chloride 0.9% |
Dextrose 5 or 10% in water |
Fat emulsion 10%, IV |
Fructose 5.25% |
Hetastarch 6% |
Invert sugar 7.5% with electrolytes |
Invert sugar 10% in water |
Ringer’s injection, lactated |
Sodium bicarbonate 1.4% |
Sodium lactate (1/6) M |
Variable |
Ringer’s injection |
Sodium chloride 0.9% |
Drug Compatibility
Compatible |
|---|
Cefotiam HCl |
Clindamycin phosphate |
Erythromycin lactobionate |
Floxacillin sodium |
Furosemide |
Incompatible |
Amikacin sulfate |
Chlorpromazine HCl |
Dopamine HCl |
Gentamicin sulfate |
Hydralazine HCl |
Prochlorperazine mesylate |
Variable |
Aztreonam |
Cefepime HCl |
Cimetidine HCl |
Heparin sodium |
Hydrocortisone sodium succinate |
Metronidazole |
Metronidazole HCl with sodium bicarbonate |
Ranitidine HCl |
Sodium bicarbonate |
Verapamil HCl |
Compatible |
|---|
Acyclovir sodium |
Amifostine |
Anidulafungin |
Aztreonam |
Bivalirudin |
Cyclophosphamide |
Dexmedetomidine HCl |
Docetaxel |
Doxapram HCl |
Doxorubicin HCl liposome injection |
Enalaprilat |
Esmolol HCl |
Etoposide phosphate |
Famotidine |
Filgrastim |
Fludarabine phosphate |
Foscarnet sodium |
Gemcitabine HCl |
Granisetron HCl |
Heparin sodium |
Heparin sodium with hydrocortisone sodium succinate |
Hetastarch in lactated electrolyte injection (Hextend) |
Labetalol HCl |
Levofloxacin |
Linezolid |
Magnesium sulfate |
Melphalan HCl |
Meperidine HCl |
Milrinone acetate |
Morphine sulfate |
Multivitamins |
Ofloxacin |
Pantoprazole sodium |
Pemetrexed disodium |
Perphenazine |
Phytonadione |
Potassium chloride |
Propofol |
Remifentanil HCl |
Tacrolimus |
Teniposide |
Theophylline |
Thiotepa |
Vitamin B complex with C |
Incompatible |
Amphotericin B cholesteryl sulfate complex |
Epinephrine HCl |
Fenoldopam mesylate |
Fluconazole |
Hydralazine HCl |
Lansoprazole |
Midazolam HCl |
Nicardipine HCl |
Ondansetron HCl |
Sargramostim |
Verapamil HCl |
Vinorelbine tartrate |
Variable |
Calcium gluconate |
Diltiazem HCl |
Hetastarch in sodium chloride 0.9% |
Hydromorphone HCl |
Vancomycin HCl |
Actions and SpectrumActions
Based on spectrum of activity, classified as an aminopenicillin.8 9 Aminopenicillins have enhanced activity against gram-negative bacteria compared with natural and penicillinase-resistant penicillins.8 9
Usually bactericidal.1 2
Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.1 2
Spectrum of activity includes many gram-positive and -negative aerobes and some anaerobes.1 9 12
Gram-positive aerobes: active in vitro and in clinical infections against Staphylococcus (β-lactamase-negative strains only), Streptococcus pneumoniae, other Streptococcus (α- and β-hemolytic strains only), and Enterococcus faecalis.1 9 12 Also active against Corynebacteriun and Listeria monocytogenes.1 9 12
Gram-negative aerobes: active in vitro and in clinical infections against H. influenzae, N. gonorrhoeae, E. coli, Proteus mirabilis, Salmonella, and Shigella.1 9 12 Also active in vitro against Bordetella pertussis, Eikenella corrodens, and Neisseria meningitidis.9 Inactive against Citrobacter, Enterobacter, Klebsiella, Providencia, and Serratia.9 12
Gram-positive and gram-negative bacteria that produce β-lactamases, including β-lactamase-producing S. aureus and E. faecalis, are resistant.9 12
Complete cross-resistance generally occurs between ampicillin and amoxicillin.
Advice to Patients
Advise patients that antibacterials (including ampicillin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).
Importance of completing the entire prescribed course of treatment, even if feeling better after a few days.
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with ampicillin or other antibacterials in the future.
Importance of taking oral ampicillin with a full glass of water 1 hour before or 2 hours after a meal.1
Importance of discontinuing therapy and informing clinician if an allergic reaction occurs.1
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.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.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 250 mg (of ampicillin)* | Principen | Sandoz |
500 mg (of ampicillin)* | Principen | Sandoz | ||
For suspension | 125 mg (of ampicillin) per 5 mL* | Principen | Sandoz | |
250 mg (of ampicillin) per 5 mL* | Principen | Sandoz |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection | 125 mg (of ampicillin) | Ampicillin Sodium for Injection | Sandoz |
250 mg (of ampicillin) | Ampicillin Sodium for Injection | Sandoz | ||
500 mg (of ampicillin) | Ampicillin Sodium for Injection | Sandoz | ||
1 g (of ampicillin) | Ampicillin Sodium for Injection | Sandoz | ||
2 g (of ampicillin) | Ampicillin Sodium for Injection | Sandoz | ||
10 g (of ampicillin) pharmacy bulk package | Ampicillin Sodium for Injection | Sandoz | ||
For injection, for IV infusion | 1 g (of ampicillin) | Ampicillin Sodium ADD-Vantage |
Knock-out
Knock-out may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Knock-out
Guaifenesin
Guaifenesin is reported as an ingredient of Knock-out in the following countries:
- Italy
International Drug Name Search
Subscribe to:
Posts (Atom)