Dosage Forms/Composition
Capsule: Each capsule contains Tetracycline 200mg/500mg
Pharmacological Index
Broad spectrum Antibiotic

Dental: Treatment of periodontitis associated with presence of Actinobacillus
actinomycetemcomitans (AA). As adjunctive therapy in recurrent aphthous ulcers. Medical: Treatment of susceptible bacterial infections of both gram-positive and gram- negative organisms; also infections due to Mycoplasma, Chlamydia, and Rickettsia; indicated for acne, exacerbations of chronic bronchitis, and treatment of gonorrhea and syphilis in patients that are allergic to penicillin; used concomitantly with metronidazole, bismuth subsalicylate and an H2-antagonist for the treatment of duodenal ulcer disease induced by H. pylori.
Pregnancy Risk Factor

Hypersensitivity to tetracycline or any component; do not administer to children less
than or equal to 8 years of age.

Use of tetracyclines during tooth development may cause permanent discoloration of
the teeth and enamel, hypoplasia and retardation of skeletal development and bone
growth with risk being the greatest for children <4 years and those receiving high doses; use with caution in patients with renal or hepatic impairment (eg, elderly) and in pregnancy; dosage modification required in patients with renal impairment since it may increase BUN as an antianabolic agent; pseudotumor cerebri has been reported with tetracycline use (usually resolves with discontinuation); outdated drug can cause nephropathy; superinfection possible; use protective measure to avoid photosensitivity.

Adverse Reactions
>10%: Gastrointestinal: Discoloration of teeth and enamel hypoplasia (young children).
Gastrointestinal: Nausea, diarrhea. <1%: Pericarditis, increased intracranial pressure, bulging fontanels in infants, pseudotumor cerebri, dermatologic effects, pruritus, pigmentation of nails, exfoliative dermatitis, diabetes insipidus syndrome, vomiting, esophagitis, anorexia, abdominal cramps, antibiotic-associated pseudomembranous colitis, staphylococcal enterocolitis, hepatotoxicity, thrombophlebitis, paresthesia, acute renal failure, azotemia, renal damage, superinfections, anaphylaxis, hypersensitivity reactions, candidal superinfection .
Symptoms of overdose include nausea, anorexia, diarrhea; following GI
decontamination. Supportive care only.

Drug Interactions
Decreased effect: Calcium-, magnesium-, or aluminum-containing antacids, oral
contraceptives, iron, zinc, sodium bicarbonate, penicillins, cimetidine may decrease tetracycline absorption. Although no clinical evidence exists, may bind with bismuth or calcium carbonate, an excipient in bismuth subsalicylate, during treatment for H. pylori. Increased toxicity: Methoxyflurane anesthesia when concurrent with tetracycline may cause fatal nephrotoxicity; warfarin with tetracyclines may result in increased anticoagulation; tetracyclines may rarely increase digoxin serum levels.

Mechanism of Action
Inhibits bacterial protein synthesis by binding with the 30S and possibly the 50S
ribosomal subunit(s) of susceptible bacteria; may also cause alterations in the cytoplasmic membrane.

Absorption: Oral: 75%
Distribution: Small amount appears in bile Relative diffusion of antimicrobial agents from blood into cerebrospinal fluid (CSF): Good only with inflammation (exceeds usual MICs) Ratio of CSF to blood level (%): Inflamed meninges: 25 Normal renal function: 8-11 hours End-stage renal disease: 57-108 hours Time to peak serum concentration: Oral: Within 2-4 hours Elimination: Primary route is the kidney, with 60% of a dose excreted as unchanged
drug in the urine; concentrated by liver in bile and feces in biologically active form
Usual Dosage
Tetracycline should be taken either one hour before meals or two hours after meals.
The maximum dose should not exceed 3 g daily. The usual dose depending on the severity of the infection is: Adults and children of 12 years and older: 250 - 500 mg every 6 hours.

Patient Information
Take this medication exactly as directed. Take all of the prescription even if you see an
improvement in your condition. Do not use more or more often than recommended. Pregnancy/breast-feeding precautions: Do not get pregnant while taking this medication - effectiveness of oral contraceptives may be reduced; use appropriate barrier contraceptive measures. Breast-feeding is not recommended.

LOMUS Drug Information Center
Lomus Pharmaceuticals Pvt. Ltd.
P.O. Box No 4506, Lomus House (Corporate office),
Kailash Chour, Lazimpat, Kathmandu, Nepal
Ph: 4436396 (Hunting Line). Fx: 977-1-4436395
E-mail: [email protected]

Source: http://www.lomus.com.np/pdf/lomus/LOMOCYCLINE.pdf

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