Septra

Name: Septra

How to use

Shake this medication well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Take this medication by mouth, as directed by your doctor, with a full glass of water (8 ounces / 240 milliliters). If stomach upset occurs, take with food or milk. Drink plenty of fluids while taking this medication to lower the unlikely risk of kidney stones forming, unless your doctor advises you otherwise. Dosage is based on your medical condition and response to treatment.Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping it too early may allow bacteria to continue to grow, which may result in a relapse of the infection.Tell your doctor if your condition persists or worsens.

Septra and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Septra falls into category D. It is strongly not recommended (“contraindicated") for use in pregnant patients because sulfonamides cross the placental barrier, which may cause brain damage to the unborn child. In addition, sulfamethoxazole and trimethoprim may interfere with folic acid activity in the body. This may further negatively affect the unborn child.

In summary, Septra should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Septra and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

You should not take Septra if you are breastfeeding. Septra is able to pass into breast milk, which may cause brain damage to your baby.

Septra Usage

Take Septra exactly as prescribed.

Septra comes in tablet form and is taken up to 4 times a day, with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Septra at the same time.

Uses For Septra

Sulfamethoxazole and trimethoprim combination is used to treat infections such as urinary tract infections, middle ear infections (otitis media), bronchitis, traveler's diarrhea, and shigellosis (bacillary dysentery). This medicine is also used to prevent or treat Pneumocystis jiroveci pneumonia or Pneumocystis carinii pneumonia (PCP), a very serious kind of pneumonia. This type of pneumonia occurs more commonly in patients whose immune systems are not working normally, such as cancer patients, transplant patients, and patients with acquired immune deficiency syndrome (AIDS).

Sulfamethoxazole and trimethoprim combination is an antibiotic. It works by eliminating the bacteria that cause many kinds of infections. This medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Warnings

FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA, AND OTHER BLOOD DYSCRASIAS.

SULFONAMIDES, INCLUDING SULFONAMIDE-CONTAINING PRODUCTS SUCH AS TRIMETHOPRIM/SULFAMETHOXAZOLE, SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR ANY SIGN OF ADVERSE REACTION. In rare instances, a skin rash may be followed by a more severe reaction, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic necrosis, and serious blood disorder (see PRECAUTIONS).

Clinical signs, such as rash, sore throat, fever, arthralgia, pallor, purpura, or jaundice may be early indications of serious reactions.

Cough, shortness of breath, and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment.

The sulfonamides should not be used for the treatment of group A beta-hemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Septra, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Adjunctive Treatment with Leucovorin for Pneumocystis jiroveci pneumonia

Treatment failure and excess mortality were observed when trimethoprim-sulfamethoxazole was used concomitantly with leucovorin for the treatment of HIV positive patients with Pneumocystis jiroveci pneumonia in a randomized placebo controlled trial.8 Co-administration of trimethoprim-sulfamethoxazole and leucovorin during treatment of Pneumocystis jiroveci pneumonia should be avoided.

How is Septra Supplied

TABLETS (pink, scored, round-shaped) containing 80 mg trimethoprim and 400 mg sulfamethoxazole: Bottles of 100 (NDC 61570-052-01). Imprint on tablets "M052".

DS (DOUBLE STRENGTH) TABLETS (pink, scored, oval-shaped) containing 160 mg trimethoprim and 800 mg sulfamethoxazole: Bottles of 20 (NDC 61570-053-20), 100 (NDC 61570-053-01), 250 (NDC 61570-053-52) and 500 (NDC 61570- 053-05). Imprint on tablets"M053".

ORAL SUSPENSIONS (pink, cherry-flavored) containing 40 mg trimethoprim and 200 mg sulfamethoxazole in each teaspoonful (5 mL): Bottle of 1 pint (473 mL) (NDC 61570-050-16) and 100 mL–package of 6 (NDC 61570-050-11); and (purple, grape-flavored) containing 40 mg trimethoprim and 200 mg sulfamethoxazole in each teaspoonful (5 mL): Bottle of 1 pint (473 mL) (NDC 61570-051-16).

Tablets should be stored at 15° to 25°C (59° to 77°F) in a dry place and protected from light.

Suspensions should be stored at 15° to 25°C (59° to 77°F) and protected from light.

PRINCIPAL DISPLAY PANEL - 20 Tablet Bottle Label

NDC 61570-053-20

Septra® DS
Double Strength
(trimethoprim and sulfamethoxazole)

Each scored tablet contains 160 mg
trimethoprim and 800 mg sulfamethoxazole.

20 Tablets
Rx Only

U.S. Patent No. 4,209,513 (Tablet)

Monarch
Pharmaceuticals®

How should I take Septra?

Take Septra exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Use Septra 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. Septra will not treat a viral infection such as the common cold or flu.

Drink plenty of fluids to prevent kidney stones while you are taking trimethoprim and sulfamethoxazole.

Septra can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Septra.

Store at room temperature away from moisture, heat, and light.

For the Consumer

Applies to sulfamethoxazole / trimethoprim: oral suspension, oral tablet

Other dosage forms:

  • intravenous solution

Along with its needed effects, sulfamethoxazole / trimethoprim 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 while taking sulfamethoxazole / trimethoprim:

Rare
  • Abdominal or stomach pain
  • black, tarry stools
  • blistering, peeling, or loosening of the skin
  • changes in skin color
  • chest pain
  • chills
  • cough or hoarseness
  • dark urine
  • diarrhea
  • dizziness
  • fever with or without chills
  • general feeling of tiredness or weakness
  • headache
  • itching
  • joint or muscle pain
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • nausea
  • pain, tenderness, or swelling of the foot or leg
  • painful or difficult urination
  • pale skin
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • swollen or painful glands
  • tightness in the chest
  • unpleasant breath odor
  • unusual bleeding or bruising
  • vomiting of blood
  • wheezing
  • yellow eyes or skin
Incidence not known
  • Abdominal or stomach tenderness
  • back, leg, or stomach pains
  • bleeding gums
  • blindness or vision changes
  • blisters, hives, or itching
  • bloating
  • blood in the urine or stools
  • bluish-colored lips, fingernails, or palms
  • burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
  • burning of the face or mouth
  • chest pain
  • cloudy urine
  • confusion
  • constipation
  • continuing ringing or buzzing or other unexplained noise in the ears
  • convulsions
  • cracks in the skin
  • decreased frequency or amount of urine
  • diarrhea, watery and severe, which may also be bloody
  • difficulty with breathing
  • difficulty with swallowing
  • fainting spells
  • general body swelling
  • general feeling of discomfort or illness
  • hair loss
  • hearing loss
  • hives
  • increased thirst
  • indigestion
  • irregular heartbeat
  • large, flat, blue, or purplish patches in the skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of heat from the body
  • muscle or joint pain
  • nosebleeds
  • not able to pass urine
  • numbness or tingling in the hands, feet, or lips
  • pain or burning while urinating
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • raised red swellings on the skin, the buttocks, legs, or ankles
  • redness of the white part of the eyes
  • redness, swelling, or soreness of the tongue
  • sores, ulcers, or white spots on the lips or in the mouth
  • soreness of the muscles
  • stiff neck or back
  • swelling of the face, hands, legs, and feet
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual weight loss
  • weakness in the hands or feet
  • weakness or heaviness of the legs
  • weight gain

Some side effects of sulfamethoxazole / trimethoprim 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:

More common
  • Passing of gas
Incidence not known
  • Discouragement
  • feeling of constant movement of self or surroundings
  • feeling sad or empty
  • increased sensitivity of the skin to sunlight
  • irritability
  • lack of feeling or emotion
  • loss of interest or pleasure
  • nervousness
  • redness or other discoloration of the skin
  • seeing, hearing, or feeling things that are not there
  • sensation of spinning
  • severe sunburn
  • trouble concentrating
  • trouble sleeping
  • uncaring
  • weight loss

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