Ampicillin Capsules

Name: Ampicillin Capsules

What are some things I need to know or do while I take Ampicillin Capsules?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine (ampicillin capsules).
  • Have your blood work checked if you are on this medicine for a long time. Talk with your doctor.
  • If you have high blood sugar (diabetes), do not use Clinitest®. Use some other urine glucose testing like Clinistix® or Tes-Tape®.
  • Do not use longer than you have been told. A second infection may happen.
  • Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this medicine (ampicillin capsules).
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Feeling very tired or weak.
  • Any unexplained bruising or bleeding.
  • Fever or chills.
  • Sore throat.
  • Black, hairy tongue.
  • Mouth irritation or mouth sores.
  • It is common to have diarrhea when taking this medicine (ampicillin capsules). Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking this medicine or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.

What are some other side effects of Ampicillin Capsules?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (ampicillin capsules), please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine (ampicillin capsules). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine (ampicillin capsules).

Review Date: October 4, 2017

Indications and Usage for Ampicillin Capsules

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin Capsules, Ampicillin for Oral Suspension and other antibacterial drugs, Ampicillin Capsules and Ampicillin for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.  When culture and susceptibility information are available, they should be considered in selecting of modifying antimicrobial therapy, in the absence of such data, local epidemiology and susceptibility patterns contribute to the empiric selection of therapy.

Ampicillin Capsules and Ampicillin for oral suspension are indicated in the treatment of infections caused by susceptible strains of the designated organisms listed below:

Infections of the genitourinary tract including gonorrhea - E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella and nonpenicillinase-producing N. gonorrhoeae.

Infections of the respiratory tract - Nonpenicillinase-producing H. influenzae and staphylococci, and streptococci including Streptococcus pneumoniae.

Infections of the gastrointestinal tract - Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci.

Meningitis - N. Meningitidis

Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to the results of susceptibility testing.

Overdosage

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures as required. In patients with renal function impairment, ampicillin-class antibiotics can be removed by hemodialysis but not by peritoneal dialysis.

How is Ampicillin Capsules Supplied

Ampicillin Capsules, USP 250 mg: Each capsule contains ampicillin trihydrate equivalent to 250 mg ampicillin. The number 2 size capsule has a gray opaque body with a light blue opaque cap, printed WC402.

Bottles of 100 NDC 67253-180-10
Bottles of 500 NDC 67253-180-50

Ampicillin Capsules, USP 500 mg: Each capsule contains ampicillin trihydrate equivalent to 500 mg ampicillin. The number 0 size capsule has a gray opaque body with a light blue opaque cap, printed WC404.

Bottles of 100 NDC 67253-181-10
Bottles of 500 NDC 67253-181-50

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

Ampicillin for Oral Suspension, USP is available as a powder which when reconstituted as directed yields a white, bubble gum flavored suspension.

Ampicillin for Oral Suspension, USP 125 mg/5 mL: Each 5 mL of reconstituted suspension contains ampicillin trihydrate equivalent to 125 mg ampicillin.

100 mL bottles NDC 67253-182-10
200 mL bottles NDC 67253-182-20

Ampicillin for Oral Suspension, USP 250 mg/5 mL: Each 5 mL of reconstituted suspension contains ampicillin trihydrate equivalent to 250 mg ampicillin.

100 mL bottles NDC 67253-183-10
200 mL bottles NDC 67253-183-20

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

Store the reconstituted suspension in a refrigerator. Discard any unused portion after 14 days.

Manufactured for:

DAVA Pharmaceuticals, Inc.
a Subsidiary of Qualitest Pharmaceuticals
Huntsville, AL  35811

Manufactured by:

Suir Pharma Ireland Ltd.
Clonmel, Ireland.

Rev. 07/15

PACKAGE/LABEL PRINCIPLE DISPLAY PANEL – 500 mg - 100capsules

     

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