"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
SUMYCIN (tetracycline) ® '250' TABLETS
SUMYCIN® '500' TABLETS
(tetracycline hydrochloride) Tablets USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sumycin '250' and Sumycin '500' Tablets (Tetracycline Hydrochloride Tablets) and other antibacterial drugs, Sumycin '250' and Sumycin '500' Tablets (Tetracycline Hydrochloride Tablets) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
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 '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 urine, fever, confusion or weakness;
- severe pain in...
What are the precautions when taking tetracycline (Sumycin)?
See also Side Effects section.
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.
Last reviewed on RxList: 2/8/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Sumycin Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.