Primaxin IM

DRUG DESCRIPTION

PRIMAXIN I.M. (Imipenem and Cilastatin for Injectable Suspension) is a formulation of imipenem (a thienamycin antibiotic) and cilastatin sodium (the inhibitor of the renal dipeptidase, dehydropeptidase I). PRIMAXIN I.M. is a potent broad spectrum antibacterial agent for intramuscular administration. Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is [5R-[5?, 6? (R*)]]-6-(1-hydroxyethyl) -3-[[2-[(iminomethyl) amino] ethyl]thio]-7-oxo-1-azabicyclo [3.2.0] hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water, and slightly soluble in methanol. Its empirical formula is C12H17N3O4SH2O, and its structural formula is:

Imipenem Structural Formula Illustration

Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is [R-[R*, S*-(Z)]]-7-[(2-amino-2-carboxyethyl)thio]-2-[[(2,2-dimethylcyclopropyl)carbonyl]amino]-2-heptenoic acid, monosodium salt. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C16H25N2O5SNa, and its structural formula is:

PRIMAXIN I.M. 500 contains 32 mg of sodium (1.4 mEq) and PRIMAXIN I.M. 750 contains 48 mg of sodium (2.1 mEq). Prepared PRIMAXIN I.M. suspensions are white to light tan in color. Variations of color within this range do not affect the potency of the product.

What are the possible side effects of imipenem and cilastatin (Primaxin IM, Primaxin IV)?

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 a serious side effect such as:

  • fast or pounding heartbeats;
  • diarrhea that is watery or bloody;
  • confusion, tremors, hallucinations, seizure (convulsions);
  • feeling light-headed, fainting;
  • fever, chills, body aches, flu symptoms;
  • nausea, stomach...

Read All Potential Side Effects and See Pictures of Primaxin IM

What are the precautions when taking imipenem and cilastatin (Primaxin IM)?

Before using imipenem with cilastatin, tell your doctor or pharmacist if you are allergic to either of its ingredients; or to penicillins or cephalosporins; 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: brain disorders (e.g., seizures, head injury, tumor), kidney disease, liver disease, stomach/intestinal diseases (e.g., colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

During pregnancy, this medication...

Read All Potential Precautions of Primaxin IM

What are the possible side effects of imipenem and cilastatin (Primaxin IM, Primaxin IV)?

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 a serious side effect such as:

  • fast or pounding heartbeats;
  • diarrhea that is watery or bloody;
  • confusion, tremors, hallucinations, seizure (convulsions);
  • feeling light-headed, fainting;
  • fever, chills, body aches, flu symptoms;
  • nausea, stomach...

Read All Potential Side Effects and See Pictures of Primaxin IM

What are the precautions when taking imipenem and cilastatin (Primaxin IM)?

Before using imipenem with cilastatin, tell your doctor or pharmacist if you are allergic to either of its ingredients; or to penicillins or cephalosporins; 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: brain disorders (e.g., seizures, head injury, tumor), kidney disease, liver disease, stomach/intestinal diseases (e.g., colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

During pregnancy, this medication...

Read All Potential Precautions of Primaxin IM


Primaxin IM Consumer (continued)

SIDE EFFECTS: Swelling, redness, pain, or soreness at the injection site may occur. This medication may also infrequently cause upset stomach, nausea, vomiting, or diarrhea. If any of these effects persist or worsen, tell 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 unlikely but serious side effects occur: dark urine, easy bruising/bleeding, hearing changes (e.g., decreased hearing, ringing in the ears), mental/mood changes (e.g., confusion, hallucinations), persistent sore throat/fever, swollen tongue, tingling hands/feet, yellowing eyes/skin, muscle twitching/spasms.

Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, unusual weakness.

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. 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 rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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 using imipenem with cilastatin, tell your doctor or pharmacist if you are allergic to either of its ingredients; or to penicillins or cephalosporins; 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: brain disorders (e.g., seizures, head injury, tumor), kidney disease, liver disease, stomach/intestinal diseases (e.g., colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.


Primaxin IM Patient Information Including Side Effects

Brand Names: Primaxin IM, Primaxin IV

Generic Name: imipenem and cilastatin (Pronunciation: IM i PEN em and SYE la STAT in)

  • What is imipenem and cilastatin (Primaxin IM)?
  • What are the possible side effects of imipenem and cilastatin (Primaxin IM)?
  • What is the most important information I should know about imipenem and cilastatin (Primaxin IM)?
  • What should I discuss with my healthcare provider before use imipenem and cilastatin (Primaxin IM)?
  • How should I use imipenem and cilastatin (Primaxin IM)?
  • What happens if I miss a dose (Primaxin IM)?
  • What happens if I overdose (Primaxin IM)?
  • What should I avoid while using imipenem and cilastatin (Primaxin IM)?
  • What other drugs will affect imipenem and cilastatin (Primaxin IM)?
  • Where can I get more information?

What is imipenem and cilastatin (Primaxin IM)?

Imipenem is an antibiotic that fights serious infections caused by bacteria.

Cilastatin helps imipenem work more effectively by preventing the breakdown of the antibiotic in the kidneys.

Imipenem and cilastatin is used to treat severe infections of the lower respiratory tract, skin, stomach, female reproductive organs, and other body systems.

Imipenem and cilastatin may also be used for other purposes not listed here.

What are the possible side effects of imipenem and cilastatin (Primaxin IM)?

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 a serious side effect such as:

  • fast or pounding heartbeats;
  • diarrhea that is watery or bloody;
  • confusion, tremors, hallucinations, seizure (convulsions);
  • feeling light-headed, fainting;
  • fever, chills, body aches, flu symptoms;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • pain, swelling, or redness where the medicine was injected;
  • mild nausea, vomiting, heartburn, or stomach pain;
  • sore throat;
  • vaginal itching or discharge;
  • mild skin rash or itching;
  • dizziness or tired feeling;
  • numbness or tingling; or
  • ringing in your ears.

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 imipenem and cilastatin (Primaxin IM)?

Do not use this medication if you are allergic to imipenem and cilastatin, or to lidocaine or other local anesthetics (numbing medicine). You should not use imipenem and cilastatin if you have heart block.

Before using imipenem and cilastatin, tell your doctor if you have kidney disease (or if you are on dialysis), or a seizure disorder.

Also tell your doctor if you are either allergic to or are currently taking a penicillin or cephalosporin antibiotic such as Amoxil, Augmentin, Bactocill, Beepen-VK, Ceclor, Ceftin, Duricef, Dycill, Dynapen, Keflex, Ledercillin VK, Omnipen, Pen-V, Pfizerpen, Principen, Veetids, and others.

Primaxin IM (for the muscle) and Primaxin IV (for the vein) are different forms of this medicine and should be used only for their specific type of injection. Do not inject Primaxin IM into a vein and do not inject Primaxin IV into a muscle.

Call your doctor at once if you have serious side effects such as pounding heartbeats, confusion, hallucinations, seizure (convulsions), feeling light-headed, fainting, flu symptoms, nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes), or a severe blistering, peeling, and red skin rash.

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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