Principen

DRUG DESCRIPTION

Ampicillin trihydrate is a semisynthetic penicillin derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Ampicillin is designated chemically as (2S, 5R, 6R)-6-[(8)-2-Amino-2-phenylacetamido]-3,3-dimethyl-t-oxo-4-thia-1- azabicyclo[3.2.0] heptane-2-carboxylic acid. The chemical formula is C16H19N3O4S3H2O and its molecular weight is 403.45.

This is the anhydrous form of ampicillin. It is prepared as the trihydrate form attached to 3 water (H2O) molecules.
PRINCIPEN Capsules (Ampicillin Capsules USP) for oral administration provide ampicillin trihydrate equivalent to 250 mg and 500 mg ampicillin.
Inactive ingredients: black iron oxide, gelatin, FD&C Blue #1, FD&C Red #3, FD&C Red #40, lactose monohydrate, silica gel, and titanium dioxide.
PRINCIPEN for Oral Suspension (Ampicillin for oral suspension USP) provide, after constitution, ampicillin trihydrate equivalent to 125 mg and 250 mg ampicillin per 5 mL.
Inactive ingredients: antifoam AF emulsion, Atmos 300, colloidal silicon dioxide, FD&C Red #40, lecithin, natural and artificial flavors, sucrose, sodium citrate, sodium benzoate, and vanillin.

What are the possible side effects of ampicillin (Principen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • diarrhea that is watery or bloody;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • urinating less than usual or not at...

Read All Potential Side Effects and See Pictures of Principen

What are the precautions when taking ampicillin (Principen)?

Before taking ampicillin, tell your doctor or pharmacist if you are allergic to it; or to penicillin or cephalosporin antibiotics; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, a certain type of viral infection (infectious mononucleosis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

Ampicillin...

Read All Potential Precautions of Principen


Principen Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, or mouth/tongue sores may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, persistent nausea or vomiting, stomach/abdominal pain, yellowing eyes or skin, easy bruising or bleeding, persistent sore throat or fever.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Ampicillin can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ampicillin, tell your doctor or pharmacist if you are allergic to it; or to penicillin or cephalosporin antibiotics; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, a certain type of viral infection (infectious mononucleosis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

Ampicillin passes into breast milk. Consult your doctor before breast-feeding.


Principen Patient Information Including Side Effects

Brand Names: Principen

Generic Name: ampicillin (Pronunciation: am pi SIL in)

  • What is ampicillin (Principen)?
  • What are the possible side effects of ampicillin (Principen)?
  • What is the most important information I should know about ampicillin (Principen)?
  • What should I discuss with my healthcare provider before taking ampicillin (Principen)?
  • How should I take ampicillin (Principen)?
  • What happens if I miss a dose (Principen)?
  • What happens if I overdose (Principen)?
  • What should I avoid while taking ampicillin (Principen)?
  • What other drugs will affect ampicillin (Principen)?
  • Where can I get more information?

What is ampicillin (Principen)?

Ampicillin is an antibiotic in the penicillin group of drugs. It fights bacteria in your body.

Ampicillin is used to treat many different types of infections caused by bacteria, such as ear infections, bladder infections, pneumonia, gonorrhea, and E. coli or salmonella infection.

Ampicillin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ampicillin (Principen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • diarrhea that is watery or bloody;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • urinating less than usual or not at all;
  • agitation, confusion, unusual thoughts or behavior; or
  • seizure (black-out or convulsions).

Less serious side effects may include

  • nausea, vomiting, stomach pain;
  • vaginal itching or discharge;
  • headache;
  • swollen, black, or "hairy" tongue; or
  • thrush (white patches or inside your mouth or throat).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ampicillin (Principen)?

Do not use this medication if you are allergic to ampicillin or to any other penicillin antibiotic, such as amoxicillin (Amoxil), carbenicillin (Geocillin), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids), and others.

Before using ampicillin, tell your doctor if you are allergic to cephalosporins such as Ceclor, Ceftin, Duricef, Keflex, and others, or if you have asthma, kidney disease, a bleeding or blood clotting disorder, mononucleosis (also called "mono"), or a history of any type of allergy.

Ampicillin can make birth control pills less effective, which may result in pregnancy. Before taking ampicillin, tell your doctor if you use birth control pills.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ampicillin will not treat a viral infection such as the common cold or flu.

Do not give this medication to another person, even if they have the same symptoms you do.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

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