Ampicillin 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ampicillin

Available from:

Crescent Pharma Ltd

ATC code:

J01CA01

INN (International Name):

Ampicillin

Dosage:

250mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010103; GTIN: 5017123075131

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMPICILLIN 250MG CAPSULES AND AMPICILLIN 500MG CAPSULES
Ampicillin (as trihydrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ampicillin Capsules are and what they are used for
2.
What you need to know before you take Ampicillin Capsules
3.
How to take Ampicillin Capsules
4.
Possible side effects
5.
How to store Ampicillin Capsules
6.
Contents of the pack and other information
1.
WHAT AMPICILLIN CAPSULES ARE AND WHAT THEY ARE USED FOR
These capsules contain the active ingredient, ampicillin (as
trihydrate). Ampicillin belongs to a group
of antibiotics called penicillins. It is used to kill bacteria which
cause infections in your body.
Ampicillin Capsules are used to treat bacterial infections including
infections of the ear and throat,
respiratory tract (e.g. lungs and chest); Urinary tract (e,g, kidneys
and bladder), heart, brain, blood
(septicaemia), abdomen (peritonitis), gonorrhoea, gastrointestinal
tract, skin and soft tissues as well as
typhoid (enteric fever) and gynaecological infections. It may also be
used following surgery to prevent
infection or for other infections determined by your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMPICILLIN CAPSULES
DO NOT TAKE AMPICILLIN CAPSULES:
•
If you have ever had an allergic reaction to ampicillin, beta lactam
antibiotics or any penicillin or
cephalosporin-type antibiotics
•
If you are allergic to any of the other ingredients of this medicine
(listed in section 6). An al

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ampicillin Capsules BP 250 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Ampicillin trihydrate BP equivalent to 250 mg of
Ampicillin.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Ampicillin capsules are presented as size 2, black/pink opaque
capsules
printed with "AMP 250" on one side and company logo on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Parenteral usage is indicated where oral dosage is inappropriate.
Ampicillin is a
broad-spectrum antibacterial indicated for treatment of commonly
occurring bacterial
infections where a sensitive organism is suspected or proven.
Lower respiratory tract - acute and chronic bronchitis, lobar and
bronchopneumonia.
Upper respiratory tract - bacterial pharyngitis, otitis media, chronic
bronchial sepsis.
Genito- urinary tract - acute cystitis, pyelonephritis for sensitive
infections,
gonorrhoea (in combination with probenecid.) and gynaecological
infections.
Other - skin and soft tissue infections, dental abscess (as an adjunct
to surgical
management), enteric fever, intra-abdominal sepsis, peritonitis and
septicaemia (in
combination with an aminoglycoside or metronidazole).
Other infections including, endocarditis and meningitis.
Ampicillin is inactivated by penicillinases including those produced
by
Staphylococcus aureus and gram-negative bacteria such as E.coli.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Usual adult dosage (including elderly patients) _
Ear, nose and throat
infections:
250mg four times a day.
Bronchitis:
Routine therapy:
250mg four times a day.
High-dosage therapy:
1 g four times a day.
Pneumonia:
500 mg four times a day.
Urinary tract infections:
500 mg three times a day.
Gonorrhoea:
2 g orally with 1 g probenecid as a
single dose.
Repeated doses are recommended for
the treatment of females.
Gastro-intestinal infections:
500-750 mg three to four times daily.
Enteric:
Acute
1-2 g four times a day for two week