Precautions

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the components of the product.Demeclocycline hydrochloride, - like other tetracycline - class antibiotics can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy, or if the patient becomes pregnant while taking these drugs, the patient ought to be aware of the dangers to the fetus. The use of tetracycline class antibiotics during tooth development (including last half of pregnancy, infancy and childhood up until the age of 8 years old) may cause permanent discoloration of teeth. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.

 

Administration of Declomycin (demeclocycline hydrochloride) has resulted in appearance of the  diabetes Isipidus syndrome (polyuria,polydipsiadiabetes insipidus and weakness) in some patients on long-term therapy. Pseudo tumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are  headache and blurred vision. The use of this antibiotic may result in overgrowth of non susceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy should be instituted. 

 

Drug Interactions

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. 

 

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. The concurrent use of tetracyclines and methoxyflurane has been reported to result in fatal renal toxicity. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium, and by iron-containing preparations. 

 

Because very serious interactions may occur: certain retinoids (acitretin,isotretinoin, tretinoin), strontium ranelate are contradicted. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting Demeclocycline. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: Digoxin, kaolin pectin, live bacterial vaccines, penicillin, or warfarin.

 

Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Not for use in patients younger than eight years of age. 

 

Adverse/Side Effects

Diarrhea, loss of appetite, nausea, vomiting, headache,dizziness, light headedness, 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-like skin reaction (sun sensitivity), darkening of the skin and other areas of the body (lips, inside of the mouth), difficult/painful swallowing, unusual increase in the amount of urine (except for the expected increase in urination if you are treating SIADH), unusual decrease in the amount of urine or no urine, unusual thirst, weakness, unusual tiredness, brown/gray tooth discoloration. Tell your doctor immediately if any of these rare but very serious side effects occur: hearing changes (ringing in the ears, decreased hearing), persistent/severe headache, vision changes (blurred vision), easy bruising/bleeding, new signs of infection (persistent sore throat, fever, chills), stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine.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 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 of the following symptoms of a serious allergic reaction, including: rash, skin sores/blisters, 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.

 

Storage Instructions

Store at controlled room temperature 20°- 25° C (68°- 77°F). Keep out of the reach of children, store away from light and moisture.