Ampitar

Package leaflet: Information for the user

Ampitar, 1 g, powder for solution for injection / infusion
Ampitar, 2 g, powder for solution for injection / infusion
Ampicillinum
Please read this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents of the leaflet:

1. What Ampitar is and what it is used for
2. Important information before using Ampitar
3. How to use Ampitar
4. Possible side effects
5. How to store Ampitar
6. Contents of the pack and other information

1. What Ampitar is and what it is used for

Ampitar contains the active substance ampicillin, which belongs to a group of medicines called penicillins. It is an antibiotic used to treat bacterial infections by killing the bacteria causing the infection. Ampitar is used to treat infections caused by bacteria sensitive to ampicillin.

Ampitar is used in the treatment of the following conditions:

• Acute exacerbation of chronic bronchitis (respiratory tract infections)
• Pyelonephritis (infection of the upper urinary tract)
• Bacterial meningitis (infection of the membranes surrounding the brain and spinal cord)
• Pneumonia, when another penicillin is ineffective or contraindicated for other reasons
• Intra-abdominal infections (infection of the stomach and intestines)
• Bacteraemia (bacterial infection of the blood) associated with any of the above infections
• Treatment and prophylaxis of endocarditis. Ampitar is also used in the treatment and prophylaxis of endocarditis (infection of the heart valves).

2. Important information before using Ampitar

When not to use Ampitar

• if the patient is allergic (hypersensitive) to ampicillin, other antibiotics known as beta-lactams (e.g. penicillin or cephalosporins), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Ampitar, discuss the following with your doctor:

• if the patient has previously experienced an allergic reaction to any antibiotic;
• if the patient has previously experienced any other allergic reaction. Hypersensitivity reactions to ampicillin may be more common in individuals with a history of allergic reactions to various substances. These reactions may present with various symptoms and degrees of severity – from skin rashes to anaphylactic shock (a severe allergic reaction);
• if the patient has kidney impairment. The doctor will adjust the dosage according to the degree of kidney impairment;
• if the patient has previously had gastrointestinal disorders, particularly colitis.

Before starting treatment with Ampitar, discuss the following with your doctor, pharmacist, or nurse:

• if the patient is allergic to cephalosporins (another group of antibacterial agents).
• if during or after treatment with ampicillin the patient develops symptoms such as watery diarrhoea, often with blood and mucus, abdominal pain and/or fever, inform the doctor immediately. These may be symptoms of inflammation of the large intestine (pseudomembranous colitis). See section 4.

Urine tests
In patients treated with ampicillin, urine glucose tests may yield false positive results. Therefore, if glucose testing is required, inform the doctor or nurse that the patient is taking Ampitar.

Ampitar and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

• Allopurinol (a medicine used to treat gout) taken concurrently with Ampitar increases the risk of skin allergic reactions.
• Methotrexate (a medicine used to treat cancer or rheumatism) – Ampitar taken at the same time may increase the adverse effects of methotrexate.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Ampicillin may be used during pregnancy if the doctor considers it necessary.

Breastfeeding
Ampicillin is excreted in human milk in small amounts. Therefore, hypersensitivity reactions, diarrhoea, or fungal colonization of mucous membranes may occur in breastfed infants, which in some cases may require discontinuation of breastfeeding.

Fertility
In animal studies, ampicillin showed no effect on fertility.

Driving and operating machinery
Ampitar has no effect or has negligible effect on the ability to drive or operate machinery. However, if adverse effects affecting concentration occur (e.g. drowsiness, see section 4. Possible side effects), driving and operating machinery are not recommended. In case of doubt, consult your doctor or pharmacist.

Ampitar contains sodium

Ampitar, 1 g:
This medicine contains 70.2 mg of sodium (the main component of table salt) per vial. This corresponds to 3.51% of the maximum recommended daily intake of sodium in the adult diet.
The maximum recommended daily dose of Ampitar contains 842.4 mg of sodium (the main component of table salt). This corresponds to 42.1% of the maximum recommended daily intake of sodium in the adult diet.
Inform your doctor or pharmacist if Ampitar is to be administered daily for a prolonged period, especially if the patient is on a low-sodium diet.
If the medicinal product is dissolved or diluted with isotonic sodium chloride solution, the additional amount of sodium from the solvent should also be taken into account.

Ampitar, 2 g:
This medicine contains 140.4 mg of sodium (the main component of table salt) per vial. This corresponds to 7.02% of the maximum recommended daily intake of sodium in the adult diet.
The maximum recommended daily dose of Ampitar contains 842.4 mg of sodium (the main component of table salt). This corresponds to 42.1% of the maximum recommended daily intake of sodium in the adult diet.
Inform your doctor or pharmacist if Ampitar is to be administered daily for a prolonged period, especially if the patient is on a low-sodium diet.
If the medicinal product is dissolved or diluted with isotonic sodium chloride solution, the additional amount of sodium from the solvent should also be taken into account.

3. How to use Ampitar

This medicine will be administered to the patient by healthcare professionals as an intramuscular injection,
an injection into one of the blood vessels, or by intravenous infusion (intravenous drip).
The doctor will determine the dose for the adult or child patient. The dosage depends on the severity of the
infection, the type of microorganism causing the infection, the patient's age and body weight.
Taking more Ampitar than recommended
If a dose of Ampitar larger than recommended is taken, or if, for example, a child accidentally ingests
the medicine, contact a doctor, hospital, or the Toxicology Information Centre (tel. 112) to assess the risk and
obtain advice.
If an excessive dose of Ampitar is taken, the following symptoms may occur: nausea, vomiting, diarrhoea,
loss of consciousness, involuntary muscle twitching, convulsions, coma, and kidney failure. In rare cases,
a severe acute allergic reaction (anaphylactic reaction) may occur within 20–40 minutes.
Missing a dose of Ampitar
If the patient thinks that a dose of Ampitar has been missed, they should immediately inform the doctor or nurse.
Do not use a double dose to make up for a missed dose.
Stopping treatment with Ampitar
Stopping treatment too early may worsen the outcome of therapy or lead to a recurrence that is more difficult to treat.
Follow the doctor's instructions.
Instructions for preparing the medicine for use are provided at the end of the package leaflet under the section
“Information intended exclusively for healthcare professionals”.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If any of the following serious side effects occur, contact a doctor immediately:

• Severe allergic reaction (anaphylactic reaction), which may be life-threatening. Symptoms may include itching and skin rash (urticaria), swelling of the face, lips, tongue, body or breathing difficulties. These symptoms may be severe and, in rare cases, may lead to death – occur rarely (less than 1 in 1,000 people).
• Ampitar may affect white blood cells, resulting in weakened immunity. If the patient develops an infection with such symptoms as fever with severe deterioration in general condition or fever with local signs of infection, for example sore throat and mouth or difficulties with urination, contact a doctor as soon as possible to confirm or exclude agranulocytosis using an appropriate test. It is important to inform the doctor about all medicines being taken. These reactions occur uncommonly (less than 1 in 100 people).
• Inflammation of the large intestine with symptoms such as watery diarrhoea, often with blood and mucus, abdominal pain and/or fever (pseudomembranous colitis). This reaction occurs uncommonly (less than 1 in 100 people).

Other side effects that may occur during treatment
The following side effects occur frequently (occur no more often than in 1 in 10 people):
loose stools
skin rash
The following side effects occur uncommonly (occur less than 1 in 100 people):
reduction in the number of red blood cells, which may lead to pale skin, weakness and breathlessness (anaemia)
reduction in the number of platelets (thrombocytopenia)
reduction or increase in the number of white blood cells (leukopenia, eosinophilia)
inflammation of the tongue and oral mucosa
nausea and vomiting
inflammation of the large intestine
diarrhoea
urticaria
The following side effects occur rarely (occur less than 1 in 1,000 people):
severe skin inflammation with peeling (exfoliative dermatitis)
skin changes, sometimes severe (erythema multiforme)
Candidiasis
Pain at the injection site may occur following intramuscular injection.
Elevated liver parameters may occur.
Reporting of side effects
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ampitar

No special storage requirements apply.
The medicine should be stored out of sight and reach of children.
The reconstituted solution should be used immediately after preparation.
Do not use this medicine after the expiry date stated on the label and outer carton following
EXP. The expiry date refers to the last day of the stated month.
Lot is the batch number.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Ampitar contains

• The active substance is ampicillin (in the form of sodium ampicillin). Ampitar, 1 g: 1 vial contains 1 g of ampicillin (as sodium ampicillin). Ampitar, 2 g: 1 vial contains 2 g of ampicillin (as sodium ampicillin). (Ampitar contains sodium. More information about sodium can be found at the end of section 2.)
• The medicine does not contain any other ingredients.

What Ampitar looks like and contents of the pack
Ampitar is a powder ranging from white to pale yellow. The pH of the prepared solution is 8.0–10.0.
Pack: 1 or 10 vials in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Telephone number: (22) 811 18 14
For further information about this medicine, please contact the marketing authorisation holder.

This medicine is authorised in the European Economic Area countries
under the following names:
Poland Ampitar
Denmark Ampitar
Sweden Ampitar
Finland Ampitar 1 g injektio-/infuusiokuiva-aine liuosta varten
Ampitar 2 g injektio-/infuusiokuiva-aine liuosta varten
Norway Ampitar

Information intended exclusively for medical professionals

Dosage
Adults:
Intramuscularly: 500 mg four times daily.
Intravenous injection: 500 mg to 2 g four to six times daily. Inject 2 g slowly over at least 3-4 minutes.
Continuous intravenous infusion: 6 to 12 g per day. An infusion pump should be used whenever possible.
Intermittent intravenous infusion: 2 g four to six times daily.
Prophylaxis of endocarditis – 2 g may be administered intravenously as a single dose 30 to 60 minutes before the procedure.
Higher intravenous doses than recommended may be administered if necessary.

Children:
Intramuscularly: 50 mg/kg body weight per day. The daily dose should be divided into four doses administered at 6-hour intervals. In neonates and premature infants, a dose of 25–50 mg/kg divided into two doses is recommended.
Intravenously: 100–200 mg/kg body weight per day in severe infections. In bacterial meningitis caused by Listeria monocytogenes, the intravenous dose in children may be increased, if necessary, up to 400 mg/kg body weight per day (divided into four doses).
Prophylaxis of endocarditis – in children, 50 mg/kg may be administered intravenously as a single dose 30 to 60 minutes before the procedure.

Monitoring of treatment
In long-term treatment (over 2–3 weeks), liver and kidney function and blood morphology should be monitored.
In cases of acute meningitis caused by Listeria monocytogenes and neonatal sepsis, ampicillin should be administered in combination with another antibiotic.
In intra-abdominal infections, ampicillin should be used in combination with other appropriate antibacterial agents when anaerobic and/or Gram-negative pathogens are known or suspected to contribute to the infectious process.

Special patient groups
Patients with renal impairment
Dosage adjustment is not necessary in patients with creatinine clearance (CrCl) >30 mL/min.
In severe renal impairment with glomerular filtration rate of 30 mL/min or less, dosage reduction is recommended due to expected accumulation of ampicillin:

• With creatinine clearance of 20–30 mL/min, reduce the usual dose to ⅔ of the normal dose.
• With creatinine clearance below 20 mL/min, reduce the usual dose to ⅓ of the normal dose. In general, in patients with severe renal impairment, ampicillin doses exceeding 1 g every 8 hours should not be administered.

Overdose
Toxicity: High doses are generally well tolerated. However, for example, in patients with impaired renal function and disrupted blood-brain barrier, parenteral administration of high doses has caused toxic symptoms. Acute reactions are mainly due to allergic reactions.
Symptoms: Toxic reactions; nausea, vomiting, diarrhea, electrolyte disturbances, decreased consciousness, muscle twitching, myoclonus, seizures, coma. Hemolytic reactions, renal function disturbances, acidosis.
In exceptional cases, anaphylactic reaction may occur within 20–40 minutes.
Treatment: Symptomatic treatment. In severe cases, hemoperfusion or hemodialysis.
In case of anaphylactic reaction: Epinephrine (adrenaline) 0.1–0.5 mg slowly intravenously. Hydrocortisone 200 mg intravenously, optionally promethazine 25 mg intravenously. Fluids. Correction of acidosis.

Special precautions for disposal
The solution should be used immediately after preparation.
Before administration, the appearance of the solution should be checked. The solution should be clear and practically free from particles.
Any unused residues of the medicinal product or its waste should be disposed of in accordance with local regulations.

Preparation of solution
Intramuscular injections
Dissolve 1 g in 4 mL of water for injections.
Intravenous injections
Dissolve 1 g in 10 mL of water for injections.
Dissolve 2 g in 20 mL of water for injections.
Intermittent infusion
Dissolve 1 g in 100 mL of isotonic sodium chloride solution (0.9%). The solution is prepared in polyolefin containers.
Dissolve 2 g in 100 mL of isotonic sodium chloride solution (0.9%) or water for injections. The solution is prepared in a polyolefin container.
Continuous infusion
Dissolve 2 g in 15 mL of water for injections. The resulting solution should be added to 500 mL of isotonic sodium chloride solution (0.9%). The solution is prepared in a polyolefin container.

Pharmaceutical incompatibilities
Do not add substances to penicillin solutions for which compatibility studies are lacking.