Sumycin

DRUG DESCRIPTION

Sumycin for oral administration contains tetracycline, an antibiotic isolated from Streptomyces aureofaciens. Tetracycline is described chemically as 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a-octa- hydro-3, 6, 10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-2-nap- thacenecarboxamide; its structural formula is:

SUMYCIN (Tetracycline Hydrochloride) structural formula illustration

Sumycin '250' and Sumycin '500' Tablets (Tetracycline Hydrochloride Tablets) are available for oral administration as tablets providing 250 mg and 500 mg tetracycline hydrochloride, respectively. Inactive ingredients: colorants (D&C Red No. 30 Aluminum lake, titanium dioxide), hypromellose, anhydrous lactose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid. In addition, 250 mg contains methylene chloride hydroxypropyl cellulose, triacetin, and 500 mg contains polyethylene glycol, polyparaben, methylparaben, sodium citrate, potassium sorbate, propylparaben, and xanthan gum.

What are the possible side effects of tetracycline (Ala-Tet, Sumycin)?

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.

Stop using tetracycline and call your doctor at once if you have any of these serious side effects:

  • severe headache, dizziness, blurred vision;
  • fever, chills, body aches, flu symptoms;
  • severe blistering, peeling, and red skin rash;
  • urinating less than usual or not at all;
  • pale or yellowed skin, dark colored...

Read All Potential Side Effects and See Pictures of Sumycin

What are the precautions when taking tetracycline (Sumycin)?

Before taking tetracycline, tell your doctor or pharmacist if you are allergic to it; or to other tetracyclines (e.g., doxycycline, minocycline), 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, liver disease, problems swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you more sensitive to the...

Read All Potential Precautions of Sumycin


Sumycin Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, loss of appetite, mouth sores, black hairy tongue, sore throat, dizziness, headache, or rectal discomfort 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 unlikely but serious side effects occur: sunburn (sun sensitivity), nail discoloration, muscle pain, difficult or painful swallowing, change in the amount of urine, brown/gray tooth discoloration, numbness/tingling of the hands/feet, unusual fatigue, new signs of infection (e.g., persistent sore throat, fever, chills).

Tell your doctor immediately if any of these rare but very serious side effects occur: hearing changes (e.g., ringing in the ears, decreased hearing), persistent or severe headache, vision changes (e.g., blurred vision), easy bruising/bleeding, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a 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 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 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, skin lesions/sores, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, new or worsening swelling/pain in the joints, chest pain, fast/irregular heartbeat.

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 tetracycline, tell your doctor or pharmacist if you are allergic to it; or to other tetracyclines (e.g., doxycycline, minocycline), 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, liver disease, problems swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are using tetracycline.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.

This medication should not be used in children younger than 8 years of age because it may cause permanent tooth discoloration and other problems. Tooth discoloration has also occurred in older children and young adults. Consult your doctor for more information.

This medication is not recommended for use during pregnancy because of possible harm to an unborn baby. Women of child-bearing age should use effective birth control while taking this medication. Consult your doctor for more details.

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


Sumycin Patient Information Including Side Effects

Brand Names: Ala-Tet, Sumycin

Generic Name: tetracycline (Pronunciation: TET tra SYE kleen)

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

What is tetracycline (Sumycin)?

Tetracycline is an antibiotic that fights bacteria in the body.

Tetracycline is used to treat many different bacterial infections, such as urinary tract infections, acne, gonorrhea, chlamydia, and others.

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

What are the possible side effects of tetracycline (Sumycin)?

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.

Stop using tetracycline and call your doctor at once if you have any of these serious side effects:

  • severe headache, dizziness, blurred vision;
  • fever, chills, body aches, flu symptoms;
  • severe blistering, peeling, and red skin rash;
  • urinating less than usual or not at all;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • loss of appetite, jaundice (yellowing of the skin or eyes); or
  • easy bruising or bleeding, unusual weakness.

Less serious side effects may include:

  • sores or swelling in your rectal or genital area;
  • mild nausea, vomiting, diarrhea, or stomach upset;
  • white patches or sores inside your mouth or on your lips;
  • swollen tongue, trouble swallowing; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tetracycline (Sumycin)?

Do not use this medication if you are pregnant. It could cause harm to the unborn baby, including permanent discoloration of the teeth later in life. Tetracycline can make birth control pills less effective. Use a second method of birth control while you are taking tetracycline to keep from getting pregnant.

Tetracycline passes into breast milk and may affect bone and tooth development in a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

Do not give tetracycline to a child younger than 8 years old. Tetracycline can cause permanent yellowing or graying of the teeth, and it can affect a child's growth.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Tetracycline can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking tetracycline. These products can make tetracycline less effective.

Throw away any unused tetracycline when it expires or when it is no longer needed. Do not take any tetracycline after the expiration date on the label has passed. Expired tetracycline can cause a dangerous syndrome resulting in damage to the kidneys.

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