LOMOCYCLINE Capsule Dosage Forms/Composition Capsule: Each capsule contains Tetracycline 200mg/500mg Pharmacological Index Broad spectrum Antibiotic INDICATION 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 D Contraindications Hypersensitivity to tetracycline or any component; do not administer to children less
than or equal to 8 years of age. Warnings/Precautions 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agent; pseudotumor cerebri has been reported with tetracycline use (usually resolves with discontinuation); outdated drug can cause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 . Overdosage/Toxicology 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. Pharmacodynamics/Kinetics 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]
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