Primsol

• FSC Laboratories, Inc.

• Taro Pharmaceuticals Usa, Inc.

Primsol is part of the drug class:

• Trimethoprim and derivatives

You should not use trimethoprim if you are allergic to it, or if you have a certain type of anemia caused by a folate (folic acid) deficiency.

Before using trimethoprim, tell your doctor if you have kidney disease, liver disease, or a folic acid deficiency.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Trimethoprim will not treat a viral infection such as the common cold or flu.

Avoid exposure to sunlight or tanning beds. Trimethoprim can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

You should not use trimethoprim if you are allergic to it, or if you have a certain type of anemia caused by a folate (folic acid) deficiency.

To make sure trimethoprim is safe for you, tell your doctor if you have any of these conditions:

• a folate (folic acid) deficiency;

• kidney disease;

• liver disease; or

• fever, sore throat, flu symptoms, pale skin, or purple or red pinpoint spots under your skin.

FDA pregnancy category C. It is not known whether trimethoprim will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Trimethoprim can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Trimethoprim should not be given to a child younger than 6 months old.

Antibacterial; dihydrofolate reductase inhibitor.106 124 Commercially available alone106 124 or in fixed combination with sulfamethoxazole.135 186

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Skin rash or itching

• Black, tarry stools
• blood in urine or stools
• bluish fingernails, lips, or skin
• changes in facial skin color
• chills
• difficult breathing or shortness of breath
• fever with or without chills
• general feeling of discomfort or illness
• headache
• joint or muscle pain
• nausea
• neck stiffness
• pale skin
• pinpoint red spots on skin
• redness, blistering, burning, tenderness, peeling, or loosening of skin or mucous membranes
• redness, swelling, or soreness of tongue
• red skin lesions, often with a purple center
• sore throat
• swelling
• thickened or scaly skin
• unusual bleeding or bruising
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• loss of appetite
• nausea or vomiting
• stomach cramps or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Primsol.
• Do not use longer than you have been told. A second infection may happen.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Primsol while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• 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 Primsol (trimethoprim oral solution), 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 Primsol. 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 Primsol.

Review Date: October 4, 2017

Applies to trimethoprim: compounding powder, oral solution, oral tablet

Dermatologic

Common (1% to 10%): Rash (e.g., maculopapular, morbilliform, pruritic), pruritus
Rare (less than 0.1%): Photosensitivity, angioedema, erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis (Lyell Syndrome
Frequency not reported: Exfoliative dermatitis, urticaria[Ref]

Gastrointestinal

Common (1% to 10%): Epigastric distress, nausea, vomiting, glossitis, abdominal pain, sore mouth
Frequency not reported: Pseudomembranous colitis, Clostridium difficile associated diarrhea[Ref]

Hematologic

Frequency not reported: Thrombocytopenia, leukopenia, neutropenia, megaloblastic anemia, methemoglobinemia[Ref]

Hepatic

Rare (less than 0.1%): Cholestatic jaundice
Frequency not reported: ALT and AST elevations, elevated bilirubin[Ref]

Hypersensitivity

Rare (less than 0.1%): Anaphylaxis[Ref]

Metabolic

Frequency not reported: Hyperkalemia, hyponatremia[Ref]

Musculoskeletal

Frequency not reported: Myalgia[Ref]

Nervous system

Rare (less than 0.1%): Aseptic meningitis, headache[Ref]

Other

Frequency not reported: Fever[Ref]

Renal

Frequency not reported: Increased BUN, increased serum creatinine[Ref]

Some side effects of Primsol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

LactMed Record Number

414

Last Revision Date

20170411

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.