1. Name of the medicinal product

Ampicillin Capsules USP 250mg Taj Pharma
Ampicillin Capsules USP 500mg Taj Pharma

  1. Qualitative and quantitative composition

a) Ampicillin Capsules USP 250mg Taj Pharma
Each hard Gelatin Capsules contains:
Ampicillin Trihydrate USP
Equivalent to Ampicillin 250mg
Excipients: Q.S.

b) Ampicillin Capsules USP 500mg Taj Pharma
Each hard Gelatin Capsules contains:

Ampicillin Trihydrate USP
Equivalent to Ampicillin 500mg
Excipients: Q.S.

For full list of excipients see section- 6

  1. Pharmaceutical form

Each hard Gelatin Capsules

  1. Clinical particulars

Therapeutic indications

Ampicillin Taj Pharma is a broad-spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by Ampicillin Taj Pharma-sensitive organisms. Typical indications include: ear, nose and throat infections, bronchitis, pneumonia, urinary tract infections, gonorrhoea, gynaecological infections, septicaemia, peritonitis, endocarditis, meningitis, enteric fever, gastro-intestinal infections.

Parenteral usage is indicated where oral dosage is inappropriate.

Posology and method of administration 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 weeks.

Carriers: 1-2 g four times a day for four to twelve weeks

Usual children’s dosage (under 10 years):

Half adult routine dosage.
All recommended dosages are a guide only. In severe infections the above dosages may be increased, or Ampicillin Taj Pharma given by injection. Oral doses of Ampicillin Taj Pharma should be taken half to one hour before meals.

Renal Impairment

In the presence of severe renal impairment (creatinine clearance <10ml/min) a reduction in dose or extension of dose interval should be considered. In cases of dialysis, an additional dose should be administered after the procedure.

Contraindications

Ampicillin Taj Pharma is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. Ampicillin Taj Pharma, penicillins, cephalosporins) or excipients.

Special warnings and precautions for use

Before initiating therapy with Ampicillin Taj Pharma, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.

Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity.

Ampicillin Taj Pharma should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of Ampicillin Taj Pharma.

Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

Dosage should be adjusted in patients with renal impairment (see section 4.2).

Interaction with other medicinal products and other forms of interaction

Bacteriostatic drugs may interfere with the bactericidal action of Ampicillin Taj Pharma.

In common with other oral broad-spectrum antibiotics, Ampicillin Taj Pharma may reduce the efficacy of oral contraceptives and patients should be warned accordingly.

Probenecid decreases the renal tubular secretion of Ampicillin Taj Pharma. Concurrent use with Ampicillin Taj Pharma may result in increased and prolonged blood levels of Ampicillin Taj Pharma.

Concurrent administration of allopurinol during treatment with Ampicillin Taj Pharma can increase the likelihood of allergic skin reactions.

It is recommended that when testing for the presence of glucose in urine during Ampicillin Taj Pharma treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of Ampicillin Taj Pharma, false positive readings are common with chemical methods.

Pregnancy and lactation

Pregnancy:

Animal studies with Ampicillin Taj Pharma have shown no teratogenic effects. The product has been in extensive clinical use since 1961 and its use in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Ampicillin Taj Pharma may be considered appropriate.

Lactation:

During lactation, trace quantities of penicillins can be detected in breast milk.

Adequate human and animal data on use of Ampicillin Taj Pharma during lactation are not available.

Effects on ability to drive and use machines

Adverse effects on the ability to drive or operate machinery have not been observed.

Undesirable effects

Hypersensitivity reactions:

If any hypersensitivity reaction occurs, the treatment should be discontinued.

Skin rash, pruritis and urticaria have been reported occasionally. The incidence is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura has also been reported. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.

As with other antibiotics, anaphylaxis (see Item 4.4 – Warnings) has been reported rarely.

Renal effects:

Interstitial nephritis can occur rarely.

Gastrointestinal reactions:

Effects include nausea, vomiting and diarrhoea. Pseudomembraneous colitis and haemorrhagic colitis have been reported rarely.

Hepatic effects:

As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely. As with most other antibiotics, a moderate and transient increase in transaminases has been reported.

Haematological effects:

As with other beta-lactams, haematological effects including transient leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely. Prolongation of bleeding time and prothrombin have also been reported rarely.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.
Ampicillin Taj Pharma may be removed from the circulation by haemodialysis.

  1. Pharmacological properties

Pharmacodynamic properties

Ampicillin Taj Pharma is a broad spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by Ampicillin Taj Pharma sensitive organisms.

Pharmacokinetic properties

Ampicillin Taj Pharma is excreted mainly in the bile and urine with a plasma half life of 1-2 hours.

Preclinical safety data

No further information of relevance to add.

  1. Pharmaceutical particulars

List of excipients

Magnesium stearate, gelatin, black and red iron oxides, titanium dioxide and erythrosine.

Incompatibilities

None.

Shelf life

Blister packs: five years
Others: three years

Special precautions for storage

Containers: Do not store above 25°C. Keep the container tightly closed.
Blisters: Do not store above 25°C. Store in the original package.

Nature and contents of container

Aluminium foil pack – 4, 16, 50, 100, 500
Aluminium/PVC tray foils blister pack – 14, 28, 56, and 100 or 500
Aluminium/PVC/PVdC blister pack – 14, 28, 56, and 100 or 500

Not all pack size may be marketed.

Special precautions for disposal and other handling

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com

Ampicillin Capsules USP 500mg Taj Pharma

PACKAGE LEAFLET – INFORMATION FOR THE PATIENT

(Ampicillin Taj Pharma 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 or pharmacist.
  • 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. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  1. What Ampicillin Taj Pharma is for
  2. Before you take Ampicillin Taj Pharma
  3. How to take Ampicillin Taj Pharma
  4. Possible side effects
  5. How to store Ampicillin Taj Pharma
  6. Further information

1. What Ampicillin Taj Pharma is for

Ampicillin Taj Pharma belongs to a group of antibiotics called penicillins. It can be used to treat many types of bacterial infection including:

  • skin and soft tissue infections
  • ear, nose and throat infections
  • bronchitis, pneumonia, chest infections
  • urinary tract infections
  • enteric fever in the acute stage and in carriers
  • infections of the female reproductive system
  • gastro-intestinal infections
  • sexually transmitted infections, such as gonorrhoea
  • blood poisoning

If you are not sure why you have been prescribed Ampicillin Taj Pharma then please ask your doctor.

  1. Before you take Ampicillin Taj Pharma

Do not take Ampicillin Taj Pharma and tell your doctor if you:

  • have ever had any unusual or allergic reactions to the active ingredients of Ampicillin Taj Pharma or any of the other ingredients of Ampicillin Taj Pharma Capsules (listed in section 6)

Warnings and precautions

Talk to your doctor before taking Ampicillin Taj Pharma if you:

  • have ever had a skin rash or swelling of the face or neck when taking any antibiotic
  • are taking any other antibiotics or medicines that contain Penicillin
  • have glandular fever or leukaemia
  • have kidney problems

Tests

If you are having a urine test to check your sugar levels tell your doctor that you are taking Ampicillin Taj Pharma as it may interfere with the results.

Other medicines and Ampicillin Taj Pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including those bought without a prescription.

This is because Ampicillin Taj Pharma can affect the way some medicines work, and some medicines can affect the way Ampicillin Taj Pharma works.

In particular, tell your doctor if you are taking any of the following:

  • any other antibiotics
  • allopurinol or probenecid, used to prevent and treat gout
  • oral contraceptive pills. There is risk of the contraceptive pill not working as well as it should and so an addition form of contraception, such as condoms, should be used.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this or any other medicine.

Driving and using machines

Ampicillin Taj Pharma should not affect your ability to operate machinery or drive.

  1. How to take Ampicillin Taj Pharma

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the capsules whole with a glass of water half an hour to an hour before meals.

Your doctor will decide your dose and length of treatment, as it depends on your condition.

The usual dosages are:

Adults including the elderly:

Ear, nose and throat infections: 250mg, four times a day (six hourly)
Skin and soft tissue infections: 250mg, four times a day (six hourly)
Bronchitis: 250mg, four times a day (six hourly)
Chronic bronchitis: 1 g, four times a day (six hourly)
Pneumonia: 500mg, four times a day (six hourly)
Urinary tract infections: 500mg, three times a day (eight hourly)
Enteric fever acute: 1-2 g, four times a day (six hourly) for 14 days
Enteric fever carriers: 1-2 g, four times a day (six hourly) for 4-12 weeks
Gastro-intestinal infections: 500-750mg, three to four times a day (six to eight hourly)
Gonorrhoea: 2 g single dose with 1 g probenecid. Repeated doses may be necessary for females.

Children:

Children under 10 years: Half the adult dose.

People with kidney problems:

Your doctor may reduce your dose.

If you take more Ampicillin Taj Pharma that you should

If you accidentally take more capsules than recommended contact your doctor or hospital casualty department at once. Take the medicine pack with you so the doctor knows what you have taken.

The symptoms of an overdose can include feeling sick (nausea), being sick (vomiting) and diarrhoea.

If you forget to take Ampicillin Taj Pharma

If you miss a dose take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose and go back to your regular dosage schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Ampicillin Taj Pharma

Do not stop taking this medicine until the prescribed course is finished, even if you feel better. If you stop taking this medicine too soon, the infection may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Ampicillin Taj Pharma can cause side effects, although not everybody gets them.

If you get any of the following side effects, STOP TAKING Ampicillin Taj Pharma and see your doctor or go to your nearest hospital straight away:

  • an allergic reaction to Ampicillin Taj Pharma, the signs of which can include red raised lumps, rashes, itching, swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing
  • Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), appearing initially as reddish target-like spots or circular patches often with central blisters. The rash may progress to widespread blistering or peeling of the skin. Additional signs include ulcers in the mouth, throat, nose or genitals, red swollen eyes (conjunctivitis) and flu-like symptoms.

If you get any of the following side effects, tell your doctor as soon as possible:

  • inflammation of the large intestines (colitis), which may cause abdominal pain, severe (watery or bloody) diarrhoea, loss of appetite and fatigue
  • inflammation of the kidneys (nephritis), which may cause blood in the urine, changes in urine output, fluid retention and high blood pressure
  • inflammation of the liver (hepatitis), which may cause yellowing of the skin or whites of the eyes (jaundice), dark urine and paler stools
  • Changes in the levels of your blood cells. These may cause symptoms including unexplained bleeding, bruising, or purplish marks on the skin, sore throat, frequent infections, fever, weakness, breathlessness and pale skin. A blood test can be taken to check.

Tell your doctor or pharmacist if you develop any of the following side effects:

  • feeling sick (nausea), being sick (vomiting), diarrhoea
  • Increase in some liver enzymes. A blood test can be taken to check.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Ampicillin Taj Pharma

Keep this medicine out of the sight and reach of children.

Keep your medicine in a dry place, below 25°C. Protect from light. Keep the capsules in the container in which they were given to you.

Do not use this medicine after the expiry date which is stated on the container. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Further information

What Ampicillin Taj Pharma contains

The active ingredient of both Ampicillin Taj Pharma 250 and 500mg Capsules is Ampicillin Taj Pharma Trihydrate, equivalent to 250mg anhydrous Ampicillin Taj Pharma in the case of Ampicillin Taj Pharma 250mg and 500mg anhydrous Ampicillin Taj Pharma in the case of Ampicillin Taj Pharma 500mg.

Ampicillin Taj Pharma 250mg and 500mg both also contain the other ingredients: magnesium stearate, gelatin, red iron oxide, black iron oxide, erythrosine and titanium dioxide.

What Ampicillin Taj Pharma looks like and contents of the pack

Ampicillin Taj Pharma 250mg and 500mg Hard gelatin capsules.

Aluminium foil pack – 4, 16, 50, 100, 500
Aluminium/PVC tray foils blister pack – 14, 28, 56, and 100 or 500
Aluminium/PVC/PVdC blister pack – 14, 28, 56, and 100 or 500

Both strengths are available in containers of 100 and 500 capsules.

Not all pack sizes may be marketed.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com